CLASSICII: Remission in Subjects With Crohn's Disease, Open Label Extension
Study Details
Study Description
Brief Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Study M02-433 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted of 2 phases: 1. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Participants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).
At Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score <150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.
At any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.
After 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).
Data are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adalimumab 40 mg every other week or every week
|
Biological: Adalimumab 40 mg eow or ew
Adalimumab 40 mg by subcutaneous injection every other week or every week
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). [Week 104]
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
Secondary Outcome Measures
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303). [Week 152]
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303). [Week 212]
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303). [Week 260]
Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303) [From Baseline of lead-in study to Week 104]
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 152]
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 212]
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 260]
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303) [Week 104]
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303) [From Baseline of lead-in Study to Week 152]
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 212]
CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 260]
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.
- Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303) [From Baseline of lead-in study to Week 104]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
- Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 152]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
- Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 212]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
- Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 260]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.
- Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303) [From Baseline of lead-in study to Week 104]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
- Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 152]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
- Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 212]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
- Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 260]
Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.
- Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248]
IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.
- Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303) [From Baseline of lead-in study to Week 104]
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
- Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 152]
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
- Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 212]
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
- Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303) [From Baseline of lead-in study to Week 260]
A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant had completed the Year 1 of Study M02-433 (NCT00055497)
-
Diagnosis of Crohn's disease
-
Willing and able to give informed consent
Exclusion Criteria:
-
Diagnosis of ulcerative colitis
-
Pregnancy or breastfeeding
-
Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
-
Previous history of active tuberculosis or listeria infection
-
Previous history of cancer other than successfully treated skin cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gastroenterology Associates of the East Bay | Berkeley | California | United States | 94705 |
| 2 | Long Beach Gastroenterology Assoc. | Long Beach | California | United States | 90806 |
| 3 | Sharp Rees-Stealy Medical Group | San Diego | California | United States | 92123 |
| 4 | Gastroenterology Assoc. of Fairfield Co. | Bridgeport | Connecticut | United States | 06606 |
| 5 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
| 6 | Wake Research Associates | Weston | Florida | United States | 33331 |
| 7 | Shafran Gastroenterology Center | Winter Park | Florida | United States | 32789 |
| 8 | Atlanta Gastroenterology Assoc. | Atlanta | Georgia | United States | 30342 |
| 9 | Southeastern Digestive & Liver Disease | Savannah | Georgia | United States | 31404 |
| 10 | Northwest Gastroenterologists, S.C. | Arlington Heights | Illinois | United States | 60005 |
| 11 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 12 | Drug Research Services, Inc. | Metairie | Louisiana | United States | 70001 |
| 13 | LSU School of Medicine | New Orleans | Louisiana | United States | 70115 |
| 14 | Digestive Disorders Associates | Annapolis | Maryland | United States | 21401 |
| 15 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 16 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 17 | Clinical Pharmacology Study Group | Worchester | Massachusetts | United States | 01610 |
| 18 | Mayo Clinic and Mayo Foundation | Rochester | Minnesota | United States | 55905 |
| 19 | Gastroenterology and Hepatology | Kansas City | Missouri | United States | 64131 |
| 20 | Glenn Gordon, MD | Mexico | Missouri | United States | 65265 |
| 21 | Deaconess Billings Clinic Research Division | Billings | Montana | United States | 59101 |
| 22 | Gastroenterology Specialties, P.C. | Lincoln | Nebraska | United States | 68503 |
| 23 | Long Island Clinical Research Associates | Great Neck | New York | United States | 11021 |
| 24 | NY Center for Clinical Research | Lake Success | New York | United States | 11042 |
| 25 | New York Presbyterian Hospital | New York | New York | United States | 10021 |
| 26 | Daniel Present | New York | New York | United States | 10029 |
| 27 | Rochester Institute for Digestive Diseases | Rochester | New York | United States | 14607 |
| 28 | UNC School of Medicine | Chapel Hill | North Carolina | United States | 27599 |
| 29 | Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | United States | 28207 |
| 30 | Carolina Research Associates | Charlotte | North Carolina | United States | 28262 |
| 31 | Digestive Health Specialists | Winston-Salem | North Carolina | United States | 27103 |
| 32 | Consultants for Clinical Research | Cincinnati | Ohio | United States | 45219 |
| 33 | Oklahoma Foundation for Digestive Disease | Oklahoma City | Oklahoma | United States | 73104 |
| 34 | Research Solutions | Tulsa | Oklahoma | United States | 74104 |
| 35 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 36 | Peter Molloy, MD | Pittsburgh | Pennsylvania | United States | 15224 |
| 37 | Diseases of the Digestive System | Chattanooga | Tennessee | United States | 37421 |
| 38 | Nashville Medical Research Institute | Nashville | Tennessee | United States | 37205 |
| 39 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22902 |
| 40 | Northwest Gastroenterology | Bellevue | Washington | United States | 98004 |
| 41 | Inland Empire Gastroenterology | Spokane | Washington | United States | 99204 |
| 42 | Tacoma Digestive Disease Center | Tacoma | Washington | United States | 98405 |
| 43 | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | United States | 53207 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Anne Camez, MD, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M02-433 Open Label
Study Results
Participant Flow
| Recruitment Details | Participants who were still receiving study drug and were evaluated at Week 56 of Study M02-433 (NCT00055497) are included in the open-label extension (OLE) (NCT01070303). Participants entered NCT00055497 from a lead-in adalimumab induction therapy study (NCT00055523). |
|---|---|
| Pre-assignment Detail | Clinical remission = CDAI <150. At Week 4 of NCT00055497, "remitters" (participants in clinical remission at Week 0 and Week 4 of NCT00055497) were randomized to double blind (DB) therapy and "non-remitters" (participants not in clinical remission at Week 0 or no longer in clinical remission at Week 4) were assigned to open-label (OL) adalimumab. |
| Arm/Group Title | All Participants in Open-Label Extension of Study M02-433 |
|---|---|
| Arm/Group Description | Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497). |
| Period Title: Overall Study | |
| STARTED | 177 |
| COMPLETED | 88 |
| NOT COMPLETED | 89 |
Baseline Characteristics
| Arm/Group Title | Remitters | Non-Remitters | Total |
|---|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. | Total of all reporting groups |
| Overall Participants | 45 | 132 | 177 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.5
(10.88)
|
38.9
(12.53)
|
38.1
(12.19)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
57.8%
|
60
45.5%
|
86
48.6%
|
| Male |
19
42.2%
|
72
54.5%
|
91
51.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
45
100%
|
132
100%
|
177
100%
|
Outcome Measures
| Title | Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303). |
|---|---|
| Description | Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 34 | 103 |
| Number [Participants] |
29
64.4%
|
71
53.8%
|
| Title | Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303). |
|---|---|
| Description | Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 30 | 87 |
| Number [Participants] |
26
57.8%
|
62
47%
|
| Title | Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303). |
|---|---|
| Description | Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 25 | 69 |
| Number [Participants] |
21
46.7%
|
45
34.1%
|
| Title | Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303). |
|---|---|
| Description | Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 10 | 27 |
| Number [Participants] |
8
17.8%
|
21
15.9%
|
| Title | Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303) |
|---|---|
| Description | A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 34 | 103 |
| Number [Participants] |
28
62.2%
|
87
65.9%
|
| Title | Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303) |
|---|---|
| Description | A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 30 | 87 |
| Number [Participants] |
28
62.2%
|
74
56.1%
|
| Title | Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303) |
|---|---|
| Description | A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212 |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 25 | 69 |
| Number [Participants] |
23
51.1%
|
58
43.9%
|
| Title | Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303) |
|---|---|
| Description | A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 10 | 27 |
| Number [Participants] |
8
17.8%
|
27
20.5%
|
| Title | Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303) |
|---|---|
| Description | A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 . |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 34 | 103 |
| Number [Participants] |
31
68.9%
|
92
69.7%
|
| Title | Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303) |
|---|---|
| Description | A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in Study to Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 30 | 87 |
| Number [Participants] |
30
66.7%
|
77
58.3%
|
| Title | Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303) |
|---|---|
| Description | CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 25 | 69 |
| Number [Participants] |
24
53.3%
|
63
47.7%
|
| Title | Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303) |
|---|---|
| Description | A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity. |
| Time Frame | From Baseline of lead-in study to Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 10 | 27 |
| Number [Participants] |
10
22.2%
|
27
20.5%
|
| Title | Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 18 | 31 |
| Number [Participants] |
8
17.8%
|
12
9.1%
|
| Title | Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 18 | 30 |
| Number [Participants] |
8
17.8%
|
14
10.6%
|
| Title | Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 14 | 23 |
| Number [Participants] |
5
11.1%
|
10
7.6%
|
| Title | Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 6 | 12 |
| Number [Participants] |
2
4.4%
|
4
3%
|
| Title | Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 18 | 31 |
| Number [Participants] |
9
20%
|
15
11.4%
|
| Title | Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 18 | 30 |
| Number [Participants] |
9
20%
|
15
11.4%
|
| Title | Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 14 | 23 |
| Number [Participants] |
6
13.3%
|
12
9.1%
|
| Title | Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303) |
|---|---|
| Description | Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit. |
| Time Frame | From Baseline of lead-in study to Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 6 | 12 |
| Number [Participants] |
2
4.4%
|
5
3.8%
|
| Title | Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores |
|---|---|
| Description | IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life. |
| Time Frame | Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point. |
| Arm/Group Title | Change From Baseline-Week 104 | Change From Baseline-Week 152 | Change From Baseline-Week 200 | Change From Baseline-Week 248 |
|---|---|---|---|---|
| Arm/Group Description | The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses. | The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses. | The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses. | The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses. |
| Measure Participants | 142 | 114 | 99 | 69 |
| Mean (Standard Deviation) [Scores on a scale] |
42.4
(36.27)
|
47.9
(33.70)
|
51.0
(32.77)
|
51.7
(32.67)
|
| Title | Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303) |
|---|---|
| Description | A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit. |
| Time Frame | From Baseline of lead-in study to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 3 | 15 |
| Number [Participants] |
1
2.2%
|
11
8.3%
|
| Title | Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303) |
|---|---|
| Description | A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit. |
| Time Frame | From Baseline of lead-in study to Week 152 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 3 | 14 |
| Number [Participants] |
2
4.4%
|
11
8.3%
|
| Title | Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303) |
|---|---|
| Description | A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit. |
| Time Frame | From Baseline of lead-in study to Week 212 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 3 | 11 |
| Number [Participants] |
1
2.2%
|
10
7.6%
|
| Title | Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303) |
|---|---|
| Description | A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit. |
| Time Frame | From Baseline of lead-in study to Week 260 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260. |
| Arm/Group Title | Remitters | Non-Remitters |
|---|---|---|
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. |
| Measure Participants | 2 | 7 |
| Number [Participants] |
2
4.4%
|
6
4.5%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (AEs), defined as AEs beginning on or after first dose of adalimumab (in NCT00055523, NCT00055497, or NCT01070303) are reported. Treatment-emergent AEs were recorded up to 70 days after last dose of adalimumab. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events are reported for all participants who entered the study (NCT00055497), N=276. These 276 participants include the 177 participants who continued into the open-label extension (NCT01070303). | |||
| Arm/Group Title | Remitters | Non-Remitters | ||
| Arm/Group Description | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497. | Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497. | ||
All Cause Mortality |
||||
| Remitters | Non-Remitters | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Remitters | Non-Remitters | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/55 (10.9%) | 69/221 (31.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/55 (0%) | 2/221 (0.9%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/55 (0%) | 2/221 (0.9%) | ||
| Cardiac tamponade | 0/55 (0%) | 1/221 (0.5%) | ||
| Coronary artery disease | 1/55 (1.8%) | 1/221 (0.5%) | ||
| Coronary artery occlusion | 0/55 (0%) | 1/221 (0.5%) | ||
| Congenital, familial and genetic disorders | ||||
| Pyloric stenosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/55 (0%) | 1/221 (0.5%) | ||
| Colonic stenosis | 1/55 (1.8%) | 1/221 (0.5%) | ||
| Constipation | 1/55 (1.8%) | 0/221 (0%) | ||
| Crohn's disease | 0/55 (0%) | 17/221 (7.7%) | ||
| Gastric ulcer | 0/55 (0%) | 1/221 (0.5%) | ||
| Gastritis | 0/55 (0%) | 1/221 (0.5%) | ||
| Gastrooesophageal reflux disease | 0/55 (0%) | 1/221 (0.5%) | ||
| Ileal stenosis | 1/55 (1.8%) | 3/221 (1.4%) | ||
| Intestinal ischaemia | 0/55 (0%) | 1/221 (0.5%) | ||
| Intestinal obstruction | 1/55 (1.8%) | 1/221 (0.5%) | ||
| Large intestine perforation | 0/55 (0%) | 1/221 (0.5%) | ||
| Oesophageal ulcer | 0/55 (0%) | 1/221 (0.5%) | ||
| Peritonitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Small intestinal obstruction | 0/55 (0%) | 8/221 (3.6%) | ||
| Small intestinal stenosis | 1/55 (1.8%) | 3/221 (1.4%) | ||
| Vomiting | 0/55 (0%) | 2/221 (0.9%) | ||
| General disorders | ||||
| Fatigue | 0/55 (0%) | 1/221 (0.5%) | ||
| Non-cardiac chest pain | 0/55 (0%) | 1/221 (0.5%) | ||
| Pain | 0/55 (0%) | 1/221 (0.5%) | ||
| Pyrexia | 0/55 (0%) | 1/221 (0.5%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Cholecystitis chronic | 0/55 (0%) | 1/221 (0.5%) | ||
| Sphincter of Oddi dysfunction | 0/55 (0%) | 1/221 (0.5%) | ||
| Infections and infestations | ||||
| Abdominal abscess | 0/55 (0%) | 2/221 (0.9%) | ||
| Abdominal wall abscess | 0/55 (0%) | 1/221 (0.5%) | ||
| Abscess | 0/55 (0%) | 1/221 (0.5%) | ||
| Abscess intestinal | 0/55 (0%) | 1/221 (0.5%) | ||
| Anal abscess | 0/55 (0%) | 1/221 (0.5%) | ||
| Appendicitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Clostridium difficile colitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Diverticulitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Folliculitis | 0/55 (0%) | 1/221 (0.5%) | ||
| Gastroenteritis | 0/55 (0%) | 1/221 (0.5%) | ||
| Lobar pneumonia | 0/55 (0%) | 1/221 (0.5%) | ||
| Meningitis viral | 0/55 (0%) | 1/221 (0.5%) | ||
| Nocardiosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Parvovirus infection | 0/55 (0%) | 1/221 (0.5%) | ||
| Pneumonia | 1/55 (1.8%) | 0/221 (0%) | ||
| Pyelonephritis | 0/55 (0%) | 1/221 (0.5%) | ||
| Rectal abscess | 0/55 (0%) | 2/221 (0.9%) | ||
| Retroperitoneal abscess | 0/55 (0%) | 1/221 (0.5%) | ||
| Sepsis | 0/55 (0%) | 1/221 (0.5%) | ||
| Septic shock | 0/55 (0%) | 1/221 (0.5%) | ||
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 0/55 (0%) | 1/221 (0.5%) | ||
| Post procedural haemorrhage | 0/55 (0%) | 1/221 (0.5%) | ||
| Spinal compression fracture | 0/55 (0%) | 1/221 (0.5%) | ||
| Wound dehiscence | 0/55 (0%) | 1/221 (0.5%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 0/55 (0%) | 2/221 (0.9%) | ||
| Obesity | 0/55 (0%) | 1/221 (0.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/55 (1.8%) | 0/221 (0%) | ||
| Intervertebral disc degeneration | 0/55 (0%) | 1/221 (0.5%) | ||
| Intervertebral disc protrusion | 0/55 (0%) | 2/221 (0.9%) | ||
| Muscular weakness | 0/55 (0%) | 1/221 (0.5%) | ||
| Osteonecrosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Langerhans' cell granulomatosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Non-Hodgkin's lymphoma | 0/55 (0%) | 1/221 (0.5%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 0/55 (0%) | 1/221 (0.5%) | ||
| Dizziness | 0/55 (0%) | 1/221 (0.5%) | ||
| Headache | 0/55 (0%) | 2/221 (0.9%) | ||
| Optic neuritis | 0/55 (0%) | 1/221 (0.5%) | ||
| Renal and urinary disorders | ||||
| Nephrolithiasis | 0/55 (0%) | 1/221 (0.5%) | ||
| Renal failure acute | 0/55 (0%) | 1/221 (0.5%) | ||
| Reproductive system and breast disorders | ||||
| Menorrhagia | 0/55 (0%) | 1/221 (0.5%) | ||
| Ovarian cyst | 0/55 (0%) | 2/221 (0.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 1/55 (1.8%) | 0/221 (0%) | ||
| Pleural effusion | 0/55 (0%) | 1/221 (0.5%) | ||
| Pulmonary embolism | 0/55 (0%) | 1/221 (0.5%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 0/55 (0%) | 1/221 (0.5%) | ||
| Haemorrhage | 0/55 (0%) | 1/221 (0.5%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Remitters | Non-Remitters | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/55 (90.9%) | 207/221 (93.7%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 3/55 (5.5%) | 11/221 (5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 3/55 (5.5%) | 5/221 (2.3%) | ||
| Abdominal distension | 3/55 (5.5%) | 23/221 (10.4%) | ||
| Abdominal pain | 12/55 (21.8%) | 42/221 (19%) | ||
| Abdominal pain upper | 3/55 (5.5%) | 10/221 (4.5%) | ||
| Abdominal tenderness | 3/55 (5.5%) | 23/221 (10.4%) | ||
| Anal fistula | 1/55 (1.8%) | 17/221 (7.7%) | ||
| Constipation | 5/55 (9.1%) | 17/221 (7.7%) | ||
| Crohn's disease | 23/55 (41.8%) | 70/221 (31.7%) | ||
| Diarrhoea | 8/55 (14.5%) | 36/221 (16.3%) | ||
| Dyspepsia | 4/55 (7.3%) | 23/221 (10.4%) | ||
| Flatulence | 2/55 (3.6%) | 17/221 (7.7%) | ||
| Gastrooesophageal reflux disease | 2/55 (3.6%) | 22/221 (10%) | ||
| Nausea | 8/55 (14.5%) | 51/221 (23.1%) | ||
| Rectal haemorrhage | 3/55 (5.5%) | 19/221 (8.6%) | ||
| Tooth impacted | 3/55 (5.5%) | 0/221 (0%) | ||
| Vomiting | 4/55 (7.3%) | 28/221 (12.7%) | ||
| General disorders | ||||
| Chest pain | 2/55 (3.6%) | 14/221 (6.3%) | ||
| Fatigue | 6/55 (10.9%) | 26/221 (11.8%) | ||
| Influenza like illness | 2/55 (3.6%) | 18/221 (8.1%) | ||
| Injection site irritation | 9/55 (16.4%) | 21/221 (9.5%) | ||
| Injection site pain | 3/55 (5.5%) | 12/221 (5.4%) | ||
| Injection site reaction | 2/55 (3.6%) | 22/221 (10%) | ||
| Pain | 0/55 (0%) | 12/221 (5.4%) | ||
| Pyrexia | 5/55 (9.1%) | 33/221 (14.9%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 3/55 (5.5%) | 2/221 (0.9%) | ||
| Infections and infestations | ||||
| Bronchitis | 3/55 (5.5%) | 15/221 (6.8%) | ||
| Fungal infection | 1/55 (1.8%) | 12/221 (5.4%) | ||
| Gastroenteritis | 1/55 (1.8%) | 13/221 (5.9%) | ||
| Influenza | 8/55 (14.5%) | 28/221 (12.7%) | ||
| Nasopharyngitis | 15/55 (27.3%) | 50/221 (22.6%) | ||
| Pharyngitis streptococcal | 3/55 (5.5%) | 4/221 (1.8%) | ||
| Respiratory tract infection viral | 3/55 (5.5%) | 3/221 (1.4%) | ||
| Sinusitis | 6/55 (10.9%) | 34/221 (15.4%) | ||
| Tooth abscess | 3/55 (5.5%) | 8/221 (3.6%) | ||
| Upper respiratory tract infection | 8/55 (14.5%) | 30/221 (13.6%) | ||
| Urinary tract infection | 4/55 (7.3%) | 24/221 (10.9%) | ||
| Viral infection | 5/55 (9.1%) | 12/221 (5.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Excoriation | 3/55 (5.5%) | 5/221 (2.3%) | ||
| Investigations | ||||
| Antinuclear antibody positive | 3/55 (5.5%) | 4/221 (1.8%) | ||
| Metabolism and nutrition disorders | ||||
| Hypokalaemia | 0/55 (0%) | 12/221 (5.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 8/55 (14.5%) | 43/221 (19.5%) | ||
| Back pain | 4/55 (7.3%) | 31/221 (14%) | ||
| Muscle spasms | 1/55 (1.8%) | 13/221 (5.9%) | ||
| Muscular weakness | 3/55 (5.5%) | 1/221 (0.5%) | ||
| Musculoskeletal pain | 3/55 (5.5%) | 13/221 (5.9%) | ||
| Myalgia | 3/55 (5.5%) | 12/221 (5.4%) | ||
| Pain in extremity | 0/55 (0%) | 19/221 (8.6%) | ||
| Nervous system disorders | ||||
| Dizziness | 5/55 (9.1%) | 12/221 (5.4%) | ||
| Headache | 8/55 (14.5%) | 47/221 (21.3%) | ||
| Psychiatric disorders | ||||
| Anxiety | 5/55 (9.1%) | 13/221 (5.9%) | ||
| Depression | 4/55 (7.3%) | 16/221 (7.2%) | ||
| Insomnia | 4/55 (7.3%) | 26/221 (11.8%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 3/55 (5.5%) | 10/221 (4.5%) | ||
| Nephrolithiasis | 2/55 (3.6%) | 13/221 (5.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3/55 (5.5%) | 17/221 (7.7%) | ||
| Epistaxis | 4/55 (7.3%) | 5/221 (2.3%) | ||
| Oropharyngeal pain | 5/55 (9.1%) | 17/221 (7.7%) | ||
| Sinus congestion | 3/55 (5.5%) | 12/221 (5.4%) | ||
| Wheezing | 4/55 (7.3%) | 6/221 (2.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 2/55 (3.6%) | 12/221 (5.4%) | ||
| Eczema | 3/55 (5.5%) | 14/221 (6.3%) | ||
| Erythema | 7/55 (12.7%) | 9/221 (4.1%) | ||
| Pruritis | 5/55 (9.1%) | 10/221 (4.5%) | ||
| Psoriasis | 3/55 (5.5%) | 7/221 (3.2%) | ||
| Rash | 8/55 (14.5%) | 32/221 (14.5%) | ||
| Rash erythematous | 4/55 (7.3%) | 4/221 (1.8%) | ||
| Skin exfoliation | 3/55 (5.5%) | 2/221 (0.9%) | ||
| Vascular disorders | ||||
| Hypertension | 1/55 (1.8%) | 15/221 (6.8%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | Abbott |
| Phone | 800-633-9110 |
- M02-433 Open Label