A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
Sponsor
Centocor, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00299546
Collaborator
Schering-Plough (Industry)
461
77
3
74.9
6
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor-alpha (TNFa). TNFa is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pain, swelling and damage from RA. Other marketed drugs that target TNFa (anti-TNFa drugs) have been shown to be effective in reducing the symptoms, signs and joint damage of RA, but have limitations with respect to safety and ease of use. This is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of a new anti-TNFa drug, golimumab, at 2 doses, injected under the skin every 4 weeks in subjects with active RA previously treated with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab). Concomitant therapy with methotrexate, sulfasalazine and/or hydroxychloroquine is permitted if the subject has tolerated these medications for at least 12 weeks prior to the first administration of study drug and is on a stable dose for at least 4 weeks prior to the first administration of study agent. The study hypothesis is that golimumab will be a safe and effective treatment for RA in subjects with active RA previously treated with at least one biologic anti-TNFa agent as measured by the American College of Rheumatology (ACR) response criteria, the Disease Activity Score 28 (DAS28) responses and the change from baseline in Health Assessment Questionnaire (HAQ), without causing unacceptable significant adverse effects. The ACR response criteria were designed to assess the level of improvement in the signs and symptoms of RA. The DAS28 responses also measure improvement in the signs and symptoms of RA using the joint examination and laboratory testing. The HAQ is a series of questions that measure a subject's impairment in physical function caused by RA. Patients will receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks until Week 24. After Week 24, all subjects receive golimumab 50 mg or 100 mg injections, and golimumab continues for all groups every 4 weeks for about 4 and a half more years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
461 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
Study Start Date
:
Feb 1, 2006
Actual Primary Completion Date
:
Aug 1, 2007
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock. |
Drug: Placebo
SC injections
Biological: Golimumab 50 mg
SC injections
|
| Experimental: Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period will be until the week-24 database lock. |
Biological: Golimumab 50 mg
SC injections
|
| Experimental: Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period will be until the week-24 database lock. |
Biological: Golimumab 100 mg
SC injections
|
Outcome Measures
Primary Outcome Measures
- American College of Rheumatology (ACR) 20 Response at Week 14. [Week 14]
ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)
Secondary Outcome Measures
- American College of Rheumatology (ACR) 50 Response at Week 14 [Week 14]
Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
- Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14 [Week 14]
DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).
- American College of Rheumatology (ACR) 20 at Week 24 [From Baseline to Week 24]
Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)
- Health Assessment Questionnaire (HAQ) Score at Week 24 [From Baseline to Week 24]
Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
-
Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline
-
Must have been previously treated with at least one dose of etanercept, adalimumab, or infliximab
-
If currently using methotrexate, sulfasalazine and/or hydroxychloroquine must have tolerated these agents for at least 12 weeks and be on a stable dose for at least 4 weeks prior to the first administration of study agent
-
If using NSAIDs or other analgesics must be on a stable dose for at least 2 weeks prior to the first administration of study agent
-
If using oral corticosteroids must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
-
Are considered eligible according to specified tuberculosis (TB) screening criteria.
Exclusion Criteria:
-
Patients cannot have other inflammatory diseases other than RA that might interfere with the evaluation of the benefit of golimumab therapy
-
No history of treatment with natalizumab, rituximab or cytotoxic agents
-
No history of demyelinating diseases such as multiple sclerosis or optic neuritis or of concurrent congestive heart failure (CHF), lymphoproliferative disease, known malignancy or history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
-
No history of, or ongoing, chronic or recurrent infectious disease
-
No serious infection within 2 months prior to first administration of study agent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Huntsville | Alabama | United States | ||
| 3 | Paradise Valley | Arizona | United States | ||
| 4 | La Jolla | California | United States | ||
| 5 | Los Angeles | California | United States | ||
| 6 | Santa Monica | California | United States | ||
| 7 | Torrance | California | United States | ||
| 8 | Upland | California | United States | ||
| 9 | Trumbull | Connecticut | United States | ||
| 10 | Aventura | Florida | United States | ||
| 11 | Jacksonville | Florida | United States | ||
| 12 | Jupiter | Florida | United States | ||
| 13 | Largo | Florida | United States | ||
| 14 | Palm Harbor | Florida | United States | ||
| 15 | Tamarac | Florida | United States | ||
| 16 | Moline | Illinois | United States | ||
| 17 | Springfield | Illinois | United States | ||
| 18 | Cedar Rapids | Iowa | United States | ||
| 19 | Witchita | Kansas | United States | ||
| 20 | Louisville | Kentucky | United States | ||
| 21 | Wheaton | Maryland | United States | ||
| 22 | Boston | Massachusetts | United States | ||
| 23 | Rochester | Minnesota | United States | ||
| 24 | Saint Louis | Missouri | United States | ||
| 25 | Syracuse | New York | United States | ||
| 26 | Charlotte | North Carolina | United States | ||
| 27 | Wilmington | North Carolina | United States | ||
| 28 | Cincinnati | Ohio | United States | ||
| 29 | Mayfield | Ohio | United States | ||
| 30 | Duncansville | Pennsylvania | United States | ||
| 31 | Pittsburgh | Pennsylvania | United States | ||
| 32 | West Reading | Pennsylvania | United States | ||
| 33 | Knoxville | Tennessee | United States | ||
| 34 | Fort Worth | Texas | United States | ||
| 35 | Houston | Texas | United States | ||
| 36 | Lubbock | Texas | United States | ||
| 37 | Arlington | Virginia | United States | ||
| 38 | Spokane | Washington | United States | ||
| 39 | Brookfield | Wisconsin | United States | ||
| 40 | Racine | Wisconsin | United States | ||
| 41 | Adelaide | Australia | |||
| 42 | Cotton Tree | Australia | |||
| 43 | Melbourne | Australia | |||
| 44 | Graz | Austria | |||
| 45 | Lainz/Wien N/A | Austria | |||
| 46 | Wien | Austria | |||
| 47 | Victoria | British Columbia | Canada | ||
| 48 | Winnipeg | Manitoba | Canada | ||
| 49 | St. John'S | Newfoundland and Labrador | Canada | ||
| 50 | Kitchener | Ontario | Canada | ||
| 51 | Newmarket | Ontario | Canada | ||
| 52 | Ottawa | Ontario | Canada | ||
| 53 | Toronto | Ontario | Canada | ||
| 54 | Sainte Foy | Quebec | Canada | ||
| 55 | Claire | Canada | |||
| 56 | Helsinki | Finland | |||
| 57 | Hyvinkaa | Finland | |||
| 58 | Jyvalskyla | Finland | |||
| 59 | Baden-Baden | Germany | |||
| 60 | Berlin | Germany | |||
| 61 | Erlangen | Germany | |||
| 62 | Hamburg | Germany | |||
| 63 | Herne | Germany | |||
| 64 | Köln | Germany | |||
| 65 | München | Germany | |||
| 66 | Vogelsang-Gommern | Germany | |||
| 67 | Würzburg | Germany | |||
| 68 | Maastricht | Netherlands | |||
| 69 | Auckland | New Zealand | |||
| 70 | Rotorua | New Zealand | |||
| 71 | Timaru | New Zealand | |||
| 72 | Santander | Spain | |||
| 73 | Sevilla | Spain | |||
| 74 | Valencia | Spain | |||
| 75 | Leeds | United Kingdom | |||
| 76 | London | United Kingdom | |||
| 77 | Oxford | United Kingdom |
Sponsors and Collaborators
- Centocor, Inc.
- Schering-Plough
Investigators
- Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
Other Study ID Numbers:
- CR006334
- C0524T11
First Posted:
Mar 7, 2006
Last Update Posted:
Feb 27, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Centocor, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg |
|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. |
| Period Title: Overall Study | |||
| STARTED | 155 | 153 | 153 |
| COMPLETED | 55 | 61 | 67 |
| NOT COMPLETED | 100 | 92 | 86 |
Baseline Characteristics
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Total of all reporting groups |
| Overall Participants | 155 | 153 | 153 | 461 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
54.8
(13.07)
|
53.9
(11.47)
|
53.7
(12.26)
|
54.1
(12.27)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
132
85.2%
|
113
73.9%
|
122
79.7%
|
367
79.6%
|
| Male |
23
14.8%
|
40
26.1%
|
31
20.3%
|
94
20.4%
|
Outcome Measures
| Title | American College of Rheumatology (ACR) 20 Response at Week 14. |
|---|---|
| Description | ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein) |
| Time Frame | Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders. |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Combined Golimumab |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg). |
| Measure Participants | 150 | 147 | 148 | 295 |
| Number [participants] |
27
17.4%
|
51
33.3%
|
54
35.3%
|
105
22.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Combined Golimumab |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a >90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40~55% ACR 20 response in golimumab groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline Methotrexate (MTX) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 2: Golimumab 50 mg |
|---|---|---|
| Comments | Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 3: Golimumab 100 mg |
|---|---|---|
| Comments | Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
| Title | American College of Rheumatology (ACR) 50 Response at Week 14 |
|---|---|
| Description | Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein). |
| Time Frame | Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders. |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Combined Golimumab |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg). |
| Measure Participants | 150 | 147 | 148 | 295 |
| Number [participants] |
10
6.5%
|
22
14.4%
|
27
17.6%
|
49
10.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Combined Golimumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline Methotrexate (MTX). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 2: Golimumab 50 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.021 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 3: Golimumab 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
| Title | Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14 |
|---|---|
| Description | DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). |
| Time Frame | Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders. |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Combined Golimumab |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg). |
| Measure Participants | 150 | 147 | 148 | 295 |
| Number [participants] |
44
28.4%
|
82
53.6%
|
87
56.9%
|
169
36.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Combined Golimumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline Methorexate (MTX). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 2: Golimumab 50 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 3: Golimumab 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
| Title | American College of Rheumatology (ACR) 20 at Week 24 |
|---|---|
| Description | Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP) |
| Time Frame | From Baseline to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx. |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Combined Golimumab |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg). |
| Measure Participants | 150 | 147 | 148 | 295 |
| Number [participants] |
24
15.5%
|
46
30.1%
|
63
41.2%
|
109
23.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Combined Golimumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline Methotrexate (MTX). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 2: Golimumab 50 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 3: Golimumab 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Stratified by baseline MTX. | |
| Title | Health Assessment Questionnaire (HAQ) Score at Week 24 |
|---|---|
| Description | Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3. |
| Time Frame | From Baseline to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment. |
| Arm/Group Title | Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Combined Golimumab |
|---|---|---|---|---|
| Arm/Group Description | Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock. | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock. | Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg). |
| Measure Participants | 150 | 147 | 148 | 295 |
| Median (Inter-Quartile Range) [scores on a scale] |
0.0000
|
0.1250
|
0.2500
|
0.2500
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Combined Golimumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | Stratified by baseline Methotrexate (MTX). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 2: Golimumab 50 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | Stratified by baseline MTX. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo, Group 3: Golimumab 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3. | |
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | Stratified by baseline MTX. | |
Adverse Events
| Time Frame | Adverse event data were collected for 5 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Only participants who received at least 1 dose of golimumab were included in the safety analysis. The total number of participants at risk for adverse events is therefore less than the number of participants who started the study. | |||||
| Arm/Group Title | Group 1: Golimumab 50 mg SC Injections Only | Group 2: Golimumab 100 mg SC Injections Only | Group 3: Golimumab 50 and 100 mg SC Injections | |||
| Arm/Group Description | Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. | Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. | Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. | |||
All Cause Mortality |
||||||
| Group 1: Golimumab 50 mg SC Injections Only | Group 2: Golimumab 100 mg SC Injections Only | Group 3: Golimumab 50 and 100 mg SC Injections | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Group 1: Golimumab 50 mg SC Injections Only | Group 2: Golimumab 100 mg SC Injections Only | Group 3: Golimumab 50 and 100 mg SC Injections | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/98 (34.7%) | 46/138 (33.3%) | 71/195 (36.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Pancytopenia | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Thrombocytopenia | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Cardiac disorders | ||||||
| Acute Coronary Syndrome | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Acute Myocardial Infarction | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Angina Pectoris | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Aortic Valve Incompetence | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Atrial Fibrillation | 0/98 (0%) | 1/138 (0.7%) | 2/195 (1%) | |||
| Atrial Flutter | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Cardiac Failure Congestive | 0/98 (0%) | 2/138 (1.4%) | 0/195 (0%) | |||
| Cardiomyopathy | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Cardiovascular Disorder | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Coronary Artery Disease | 1/98 (1%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Myocardial Infarction | 0/98 (0%) | 2/138 (1.4%) | 0/195 (0%) | |||
| Sick Sinus Syndrome | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Supraventricular Tachycardia | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Tachycardia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Torsade De Pointes | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Congenital, familial and genetic disorders | ||||||
| Branchial Cleft Cyst | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Endocrine disorders | ||||||
| Adrenal Insufficiency | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 1/98 (1%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Colitis | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Colitis Ulcerative | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Colonic Polyp | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Diarrhoea | 1/98 (1%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Diverticulum Intestinal | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Gastric Polyps | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Gastritis | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Gastritis Erosive | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Gastrointestinal Disorder | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Inguinal Hernia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Large Intestine Perforation | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Nausea | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Oesophagitis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pancreatitis | 0/98 (0%) | 2/138 (1.4%) | 0/195 (0%) | |||
| Rectal Haemorrhage | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Small Intestinal Obstruction | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Splenic Artery Aneurysm | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Varices Oesophageal | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Vomiting | 2/98 (2%) | 0/138 (0%) | 0/195 (0%) | |||
| General disorders | ||||||
| Chest Pain | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Device Breakage | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Device Dislocation | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Device Failure | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Generalised Oedema | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Hernia | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Multi-Organ Failure | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Non-Cardiac Chest Pain | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pain | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Pyrexia | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Hepatobiliary disorders | ||||||
| Bile Duct Stone | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Biliary Cirrhosis Primary | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Cholecystitis | 1/98 (1%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Cholecystitis Acute | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Cholecystitis Chronic | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Cholelithiasis | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Drug-Induced Liver Injury | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Infections and infestations | ||||||
| Abdominal Abscess | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Appendicitis | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Bacteraemia | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Bronchitis | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Cellulitis | 1/98 (1%) | 1/138 (0.7%) | 2/195 (1%) | |||
| Cellulitis Streptococcal | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Diverticulitis | 0/98 (0%) | 2/138 (1.4%) | 2/195 (1%) | |||
| Erysipelas | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Extradural Abscess | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Gastroenteritis | 0/98 (0%) | 1/138 (0.7%) | 2/195 (1%) | |||
| Gastroenteritis Salmonella | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Herpes Zoster | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Histoplasmosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Histoplasmosis Disseminated | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Infected Skin Ulcer | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Infection | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Intervertebral Discitis | 1/98 (1%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Lung Infection Pseudomonal | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Osteomyelitis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pelvic Abscess | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Periorbital Cellulitis | 1/98 (1%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Pneumonia | 3/98 (3.1%) | 5/138 (3.6%) | 10/195 (5.1%) | |||
| Post Procedural Infection | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pulmonary Tuberculosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pyelonephritis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Salpingitis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Sepsis | 0/98 (0%) | 1/138 (0.7%) | 5/195 (2.6%) | |||
| Staphylococcal Abscess | 1/98 (1%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Staphylococcal Infection | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Subcutaneous Abscess | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Tracheobronchitis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Upper Respiratory Tract Infection | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Urinary Tract Infection | 0/98 (0%) | 2/138 (1.4%) | 5/195 (2.6%) | |||
| Urosepsis | 2/98 (2%) | 0/138 (0%) | 0/195 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ankle Fracture | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Concussion | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Contusion | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Femoral Neck Fracture | 1/98 (1%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Femur Fracture | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Fractured Sacrum | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Hip Fracture | 1/98 (1%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Humerus Fracture | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Lower Limb Fracture | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Meniscus Lesion | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Muscle Rupture | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Open Fracture | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Pelvic Fracture | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Pubis Fracture | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Stress Fracture | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Wound Dehiscence | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Diabetic Ketoacidosis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Hyponatraemia | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/98 (1%) | 2/138 (1.4%) | 1/195 (0.5%) | |||
| Arthritis | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Back Pain | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Bone Disorder | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Bursitis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Compartment Syndrome | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Intervertebral Disc Protrusion | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Joint Effusion | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Joint Swelling | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Lumbar Spinal Stenosis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Mobility Decreased | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Neck Pain | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Osteoarthritis | 2/98 (2%) | 1/138 (0.7%) | 8/195 (4.1%) | |||
| Osteonecrosis | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Osteoporosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pain in Extremity | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Rheumatoid Arthritis | 4/98 (4.1%) | 2/138 (1.4%) | 8/195 (4.1%) | |||
| Rheumatoid Nodule | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Rotator Cuff Syndrome | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Scleroderma | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Spinal Column Stenosis | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Spondylolisthesis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Synovitis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Tenosynovitis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| B-Cell Lymphoma | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Basal Cell Carcinoma | 0/98 (0%) | 3/138 (2.2%) | 1/195 (0.5%) | |||
| Breast Cancer | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Cervix Carcinoma | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Diffuse Large B-Cell Lymphoma | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Leukaemia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Lung Carcinoma Cell Type Unspecified Stage Iv | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Lymphoma | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Pancreatic Carcinoma | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Rectal Cancer | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Squamous Cell Carcinoma | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Squamous Cell Carcinoma of Skin | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Thyroid Adenoma | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Urinary Tract Neoplasm | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Nervous system disorders | ||||||
| Carpal Tunnel Syndrome | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Cerebrovascular Accident | 1/98 (1%) | 3/138 (2.2%) | 1/195 (0.5%) | |||
| Cervicobrachial Syndrome | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Convulsion | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Demyelination | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Hypoaesthesia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Migraine | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Neuralgia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Paraesthesia | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Presyncope | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Sciatica | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Syncope | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Transient Ischaemic Attack | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Viith Nerve Paralysis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Psychiatric disorders | ||||||
| Depression | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Mental Status Changes | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Renal and urinary disorders | ||||||
| Calculus Urinary | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Renal Disorder | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Renal Failure | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Renal Failure Acute | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Renal Tubular Necrosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Vesical Fistula | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Reproductive system and breast disorders | ||||||
| Endometriosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Female Genital Tract Fistula | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Uterine Haemorrhage | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Alveolitis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Asthma | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Dyspnoea | 0/98 (0%) | 2/138 (1.4%) | 1/195 (0.5%) | |||
| Mediastinal Mass | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pleural Fibrosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Pleurisy | 0/98 (0%) | 1/138 (0.7%) | 1/195 (0.5%) | |||
| Pneumonitis | 1/98 (1%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Pulmonary Embolism | 1/98 (1%) | 2/138 (1.4%) | 1/195 (0.5%) | |||
| Pulmonary Hypertension | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Psoriasis | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Surgical and medical procedures | ||||||
| Drug Detoxification | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Vascular disorders | ||||||
| Aortic Thrombosis | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Deep Vein Thrombosis | 0/98 (0%) | 3/138 (2.2%) | 0/195 (0%) | |||
| Haematoma | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Haemorrhage | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Hypertension | 0/98 (0%) | 0/138 (0%) | 2/195 (1%) | |||
| Hypotension | 0/98 (0%) | 1/138 (0.7%) | 0/195 (0%) | |||
| Labile Blood Pressure | 1/98 (1%) | 0/138 (0%) | 0/195 (0%) | |||
| Orthostatic Hypotension | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
| Subclavian Artery Stenosis | 0/98 (0%) | 0/138 (0%) | 1/195 (0.5%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Group 1: Golimumab 50 mg SC Injections Only | Group 2: Golimumab 100 mg SC Injections Only | Group 3: Golimumab 50 and 100 mg SC Injections | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 76/98 (77.6%) | 117/138 (84.8%) | 172/195 (88.2%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 5/98 (5.1%) | 4/138 (2.9%) | 4/195 (2.1%) | |||
| Eye disorders | ||||||
| Dry Eye | 5/98 (5.1%) | 4/138 (2.9%) | 5/195 (2.6%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 4/98 (4.1%) | 22/138 (15.9%) | 28/195 (14.4%) | |||
| Gastrooesophageal Reflux Disease | 1/98 (1%) | 6/138 (4.3%) | 10/195 (5.1%) | |||
| Nausea | 9/98 (9.2%) | 18/138 (13%) | 21/195 (10.8%) | |||
| Vomiting | 3/98 (3.1%) | 12/138 (8.7%) | 7/195 (3.6%) | |||
| General disorders | ||||||
| Fatigue | 2/98 (2%) | 16/138 (11.6%) | 16/195 (8.2%) | |||
| Injection Site Erythema | 6/98 (6.1%) | 13/138 (9.4%) | 18/195 (9.2%) | |||
| Oedema Peripheral | 3/98 (3.1%) | 10/138 (7.2%) | 11/195 (5.6%) | |||
| Pyrexia | 2/98 (2%) | 4/138 (2.9%) | 10/195 (5.1%) | |||
| Immune system disorders | ||||||
| Seasonal Allergy | 2/98 (2%) | 9/138 (6.5%) | 2/195 (1%) | |||
| Infections and infestations | ||||||
| Bronchitis | 11/98 (11.2%) | 22/138 (15.9%) | 24/195 (12.3%) | |||
| Ear Infection | 2/98 (2%) | 7/138 (5.1%) | 8/195 (4.1%) | |||
| Influenza | 4/98 (4.1%) | 7/138 (5.1%) | 15/195 (7.7%) | |||
| Nasopharyngitis | 10/98 (10.2%) | 26/138 (18.8%) | 37/195 (19%) | |||
| Oral Herpes | 6/98 (6.1%) | 9/138 (6.5%) | 7/195 (3.6%) | |||
| Pneumonia | 2/98 (2%) | 7/138 (5.1%) | 6/195 (3.1%) | |||
| Rhinitis | 2/98 (2%) | 9/138 (6.5%) | 2/195 (1%) | |||
| Sinusitis | 19/98 (19.4%) | 23/138 (16.7%) | 35/195 (17.9%) | |||
| Upper Respiratory Tract Infection | 25/98 (25.5%) | 43/138 (31.2%) | 49/195 (25.1%) | |||
| Urinary Tract Infection | 13/98 (13.3%) | 12/138 (8.7%) | 22/195 (11.3%) | |||
| Viral Infection | 2/98 (2%) | 7/138 (5.1%) | 4/195 (2.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 2/98 (2%) | 8/138 (5.8%) | 12/195 (6.2%) | |||
| Excoriation | 3/98 (3.1%) | 6/138 (4.3%) | 10/195 (5.1%) | |||
| Laceration | 2/98 (2%) | 7/138 (5.1%) | 14/195 (7.2%) | |||
| Investigations | ||||||
| Alanine Aminotransferase Increased | 6/98 (6.1%) | 0/138 (0%) | 5/195 (2.6%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 12/98 (12.2%) | 20/138 (14.5%) | 25/195 (12.8%) | |||
| Back Pain | 8/98 (8.2%) | 17/138 (12.3%) | 36/195 (18.5%) | |||
| Bursitis | 4/98 (4.1%) | 6/138 (4.3%) | 10/195 (5.1%) | |||
| Joint Swelling | 1/98 (1%) | 8/138 (5.8%) | 3/195 (1.5%) | |||
| Muscle Spasms | 1/98 (1%) | 12/138 (8.7%) | 6/195 (3.1%) | |||
| Musculoskeletal Pain | 2/98 (2%) | 9/138 (6.5%) | 15/195 (7.7%) | |||
| Osteoarthritis | 3/98 (3.1%) | 5/138 (3.6%) | 13/195 (6.7%) | |||
| Pain in Extremity | 4/98 (4.1%) | 9/138 (6.5%) | 16/195 (8.2%) | |||
| Rheumatoid Arthritis | 14/98 (14.3%) | 23/138 (16.7%) | 53/195 (27.2%) | |||
| Tendonitis | 4/98 (4.1%) | 12/138 (8.7%) | 16/195 (8.2%) | |||
| Nervous system disorders | ||||||
| Dizziness | 4/98 (4.1%) | 8/138 (5.8%) | 10/195 (5.1%) | |||
| Headache | 14/98 (14.3%) | 14/138 (10.1%) | 19/195 (9.7%) | |||
| Hypoaesthesia | 2/98 (2%) | 8/138 (5.8%) | 5/195 (2.6%) | |||
| Paraesthesia | 4/98 (4.1%) | 8/138 (5.8%) | 11/195 (5.6%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 1/98 (1%) | 12/138 (8.7%) | 11/195 (5.6%) | |||
| Depression | 3/98 (3.1%) | 8/138 (5.8%) | 18/195 (9.2%) | |||
| Insomnia | 0/98 (0%) | 11/138 (8%) | 11/195 (5.6%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 10/98 (10.2%) | 13/138 (9.4%) | 24/195 (12.3%) | |||
| Oropharyngeal Pain | 4/98 (4.1%) | 8/138 (5.8%) | 15/195 (7.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 4/98 (4.1%) | 8/138 (5.8%) | 19/195 (9.7%) | |||
| Vascular disorders | ||||||
| Hypertension | 10/98 (10.2%) | 17/138 (12.3%) | 34/195 (17.4%) | |||
Limitations/Caveats
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Associate Director Clinical Research |
|---|---|
| Organization | Centocor Research & Development, Inc. |
| Phone | 1-800-457-6399 |
Responsible Party:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
Other Study ID Numbers:
- CR006334
- C0524T11
First Posted:
Mar 7, 2006
Last Update Posted:
Feb 27, 2014
Last Verified:
Jan 1, 2014