GO-FORWARD: An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Sponsor
Centocor, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00264550
Collaborator
Schering-Plough (Industry)
444
52
4
77
8.5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a randomized (treatment is assigned by chance), double-blind (neither the physician nor the patient is aware of the received treatment), placebo-controlled study of multiple subcutaneous (SC) administrations of golimumab at 2 doses as monotherapy or in combination with MTX in patients with active RA despite treatment with MTX. The duration of participation in the study for an individual patient will be upto 268 weeks. The patients will be randomly assigned in a 3:3:2:2 ratio to receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20 and methotrexate or placebo capsules will be given in addition. At Week 24, all subjects will receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years. At Week 16 any patient in the study who meets criteria for < 20% improvement from baseline in both swollen and tender joint count will enter early escape in a double-blinded fashion. Treatment during the long-term extension will start at Week 52 and continue every 4 weeks thereafter for a total of approximately 5 years from the initial (Week 0) administration of study agent. Patients will return for scheduled follow-up visits generally every 12 weeks for a total length of follow-up of approximately 5 years from the first administration of the study drug.
Study Design
Study Type:
Interventional
Actual Enrollment
:
444 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-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Sep 1, 2007
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group 1: Placebo + Methotrexate Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock. |
Drug: Methotrexate
Participants will receive methotrexate capsules weekly.
Drug: Placebo injection
Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.
|
| Experimental: Group 2: Golimumab 100 mg + Placebo Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock. |
Drug: Golimumab 100 mg
Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
Drug: Placebo capsules
Participants will receive placebo capsules weekly
|
| Experimental: Group 3: Golimumab 50 mg + Methotrexate Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock. |
Drug: Golimumab 50 mg
Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.
Drug: Methotrexate
Participants will receive methotrexate capsules weekly.
|
| Experimental: Group 4: Golimumab 100 mg + Methotrexate Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock. |
Drug: Golimumab 100 mg
Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.
Drug: Methotrexate
Participants will receive methotrexate capsules weekly.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 [Week 14]
ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 [Baseline (Week 0) and Week 24]
HAQ is 20-question instrument that 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 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
Secondary Outcome Measures
- Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14 [Week 14]
DAS 28 using CRP is an index to measure the 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). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).
- Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24 [Week 24]
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 [Baseline (Week 0) and Week 14]
The HAQ is 20-question instrument that 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 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).
- Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24 [Baseline (Week 0) and Week 24]
The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
-
Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks 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, and at least 2 of the following 4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
-
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:
-
Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
-
Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent
-
Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)
-
Have had history of, or ongoing, chronic or recurrent infectious disease.
-
Have serious infection within 2 months prior to first administration of study agent
-
Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mobile | Alabama | United States | ||
| 2 | Palo Alto | California | United States | ||
| 3 | Pasadena | California | United States | ||
| 4 | Upland | California | United States | ||
| 5 | Ormond Beach | Florida | United States | ||
| 6 | Palm Harbor | Florida | United States | ||
| 7 | Moline | Illinois | United States | ||
| 8 | Kansas City | Missouri | United States | ||
| 9 | Saint Louis | Missouri | United States | ||
| 10 | Lincoln | Nebraska | United States | ||
| 11 | Omaha | Nebraska | United States | ||
| 12 | Duncansville | Pennsylvania | United States | ||
| 13 | Richmond | Virginia | United States | ||
| 14 | Buenos Aires | Argentina | |||
| 15 | Cordoba | Argentina | |||
| 16 | Rosario | Argentina | |||
| 17 | S.M. De Tucuman | Argentina | |||
| 18 | San Miguel De Tucuman | Argentina | |||
| 19 | Clayton | Australia | |||
| 20 | Maroochydore | Australia | |||
| 21 | Melbourne | Australia | |||
| 22 | Victoria | British Columbia | Canada | ||
| 23 | St. John'S | Newfoundland and Labrador | Canada | ||
| 24 | Ottawa | Ontario | Canada | ||
| 25 | Toronto | Ontario | Canada | ||
| 26 | Sainte Foy | Quebec | Canada | ||
| 27 | Hamilton Ontario | Canada | |||
| 28 | Rancagua | Chile | |||
| 29 | Santiago De Chile | Chile | |||
| 30 | Santiago | Chile | |||
| 31 | Temuco Ix | Chile | |||
| 32 | Berlin | Germany | |||
| 33 | Hamburg | Germany | |||
| 34 | Hannover | Germany | |||
| 35 | Köln | Germany | |||
| 36 | Leipzig | Germany | |||
| 37 | Rostock | Germany | |||
| 38 | Budepest | Hungary | |||
| 39 | Anyang | Korea, Republic of | |||
| 40 | Daegu | Korea, Republic of | |||
| 41 | Pusan | Korea, Republic of | |||
| 42 | Seoul | Korea, Republic of | |||
| 43 | Monterrey | Mexico | |||
| 44 | Auckland | New Zealand | |||
| 45 | Rotorua | New Zealand | |||
| 46 | Timaru | New Zealand | |||
| 47 | Elblag | Poland | |||
| 48 | Kalisz | Poland | |||
| 49 | Szczecin | Poland | |||
| 50 | Warsaw | Poland | |||
| 51 | Warszawa N/A | Poland | |||
| 52 | Kaohsiung County | Taiwan |
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:
NCT00264550
Other Study ID Numbers:
- CR006343
- C0524T06
- 2004-003296-36
First Posted:
Dec 13, 2005
Last Update Posted:
Apr 29, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Centocor, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 444 participants were enrolled at 60 sites in 12 countries. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. |
| Period Title: Overall Study | ||||
| STARTED | 133 | 133 | 89 | 89 |
| COMPLETED | 90 | 92 | 72 | 59 |
| NOT COMPLETED | 43 | 41 | 17 | 30 |
Baseline Characteristics
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Total of all reporting groups |
| Overall Participants | 133 | 133 | 89 | 89 | 444 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
51.2
(11.96)
|
50
(11.47)
|
50.3
(10.98)
|
50
(10.78)
|
50.4
(11.36)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
109
82%
|
105
78.9%
|
72
80.9%
|
72
80.9%
|
358
80.6%
|
| Male |
24
18%
|
28
21.1%
|
17
19.1%
|
17
19.1%
|
86
19.4%
|
Outcome Measures
| Title | Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 |
|---|---|
| Description | ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein. |
| Time Frame | Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Number [Participants] |
44
33.1%
|
59
44.4%
|
49
55.1%
|
50
56.2%
|
99
22.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05. | |
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide >90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III & IV). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide >90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III & IV). | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I & II provides >85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14 |
|---|---|
| Description | DAS 28 using CRP is an index to measure the 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). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response). |
| Time Frame | Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Number [Participants] |
67
50.4%
|
84
63.2%
|
64
71.9%
|
67
75.3%
|
131
29.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 |
|---|---|
| Description | HAQ is 20-question instrument that 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 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled). |
| Time Frame | Baseline (Week 0) and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Median (Inter-Quartile Range) [Units on a scale] |
0.1250
|
0.1250
|
0.3750
|
0.5000
|
0.4375
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05. | |
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance. | |
| 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 | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| Comments | Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance. | |
| 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 | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.240 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
| Title | Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24 |
|---|---|
| Description | An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP). |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Number [Participants] |
37
27.8%
|
47
35.3%
|
53
59.6%
|
53
59.6%
|
106
23.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.187 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14 |
|---|---|
| Description | The HAQ is 20-question instrument that 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 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled). |
| Time Frame | Baseline (Week 0) and Week 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Median (Inter-Quartile Range) [Units on a scale] |
0.1250
|
0.2500
|
0.3750
|
0.3750
|
0.3750
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA on van der Waerden noramal | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| 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 | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| 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 | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.097 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores | |
| Comments | ||
| Title | Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24 |
|---|---|
| Description | The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. |
| Time Frame | Baseline (Week 0) and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomly assigned to each treatment group |
| Arm/Group Title | Group 1: Placebo + Methotrexate | Group 2: Golimumab 100 mg + Placebo | Group 3: Golimumab 50 mg + Methotrexate | Group 4: Golimumab 100 mg + Methotrexate | Combined Golimumab + Methotrexate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock. | Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate) |
| Measure Participants | 133 | 133 | 89 | 89 | 178 |
| Median (Inter-Quartile Range) [Units on a scale] |
0.00
(2.354)
|
0.00
(1.598)
|
0.00
(2.740)
|
0.00
(1.342)
|
0.00
(2.159)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Combined Golimumab + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.551 |
| Comments | ||
| Method | ANOVA on van der Waerden normal | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 3: Golimumab 50 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.953 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 4: Golimumab 100 mg + Methotrexate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.293 |
| Comments | ||
| Method | ANOVA on van der waerden normal scores | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Placebo + Methotrexate, Group 2: Golimumab 100 mg + Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.361 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores | |
| Comments | ||
Adverse Events
| Time Frame | Adverse event data were collected for 5 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data. | |||||
| 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 also received methotrexate capsules throughout the study. | Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout 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. Participants also received either methotrexate or placebo capsules throughout 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 | 33/105 (31.4%) | 84/184 (45.7%) | 55/145 (37.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/105 (0%) | 2/184 (1.1%) | 2/145 (1.4%) | |||
| Lymphadenopathy | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Cardiac disorders | ||||||
| Acute Myocardial Infarction | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Angina Unstable | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Arteriosclerosis Coronary Artery | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Atrial Fibrillation | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Atrioventricular Block | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Cardiac Failure | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Cardiovascular Insufficiency | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Congestive Cardiomyopathy | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Coronary Artery Disease | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Cyanosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Dressler's Syndrome | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Myocardial Infarction | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Myocardial Ischaemia | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Supraventricular Tachycardia | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Deafness Neurosensory | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Endocrine disorders | ||||||
| Goitre | 2/105 (1.9%) | 0/184 (0%) | 2/145 (1.4%) | |||
| Eye disorders | ||||||
| Retinal Detachment | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Scleritis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Scotoma | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 0/105 (0%) | 1/184 (0.5%) | 2/145 (1.4%) | |||
| Abdominal Pain Upper | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Colitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Diarrhoea | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Diverticulum Intestinal | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Duodenal Ulcer | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Gastric Ulcer | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Gastrointestinal Haemorrhage | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Gastrooesophageal Reflux Disease | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Inguinal Hernia | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Oesophagitis Ulcerative | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Pancreatitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pancreatitis Acute | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Parotid Gland Enlargement | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Small Intestinal Obstruction | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| General disorders | ||||||
| Chest Pain | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Necrosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Pain | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pyrexia | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Hepatobiliary disorders | ||||||
| Acute Hepatic Failure | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Biliary Colic | 0/105 (0%) | 0/184 (0%) | 2/145 (1.4%) | |||
| Cholecystitis | 0/105 (0%) | 0/184 (0%) | 2/145 (1.4%) | |||
| Cholelithiasis | 0/105 (0%) | 5/184 (2.7%) | 3/145 (2.1%) | |||
| Hepatitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Immune system disorders | ||||||
| Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Sarcoidosis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Infections and infestations | ||||||
| Abscess Limb | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Arthritis Bacterial | 1/105 (1%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Arthritis Infective | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Bronchitis | 0/105 (0%) | 2/184 (1.1%) | 1/145 (0.7%) | |||
| Cellulitis | 1/105 (1%) | 4/184 (2.2%) | 1/145 (0.7%) | |||
| Chronic Sinusitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Chronic Tonsillitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Disseminated Tuberculosis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Diverticulitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Empyema | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Gastroenteritis | 0/105 (0%) | 2/184 (1.1%) | 1/145 (0.7%) | |||
| Hepatitis E | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Herpes Zoster | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Incision Site Cellulitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lobar Pneumonia | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lower Respiratory Tract Infection | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Mastoiditis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Osteomyelitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Otitis Externa | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Peritoneal Tuberculosis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pneumonia | 2/105 (1.9%) | 3/184 (1.6%) | 2/145 (1.4%) | |||
| Pneumonia Primary Atypical | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Postoperative Wound Infection | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pulmonary Tuberculosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Pyelonephritis | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Pyelonephritis Acute | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Sepsis | 1/105 (1%) | 5/184 (2.7%) | 1/145 (0.7%) | |||
| Septic Arthritis Staphylococcal | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Septic Shock | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Sinusitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Subcutaneous Abscess | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Tuberculous Pleurisy | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Upper Respiratory Tract Infection | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Urinary Tract Infection | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Vulval Cellulitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Injury, poisoning and procedural complications | ||||||
| Abdominal Injury | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Ankle Fracture | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Brain Contusion | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Clavicle Fracture | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Contusion | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Craniocerebral Injury | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Femoral Neck Fracture | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Femur Fracture | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Foot Fracture | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Hand Fracture | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Laceration | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Ligament Sprain | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Limb Crushing Injury | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Limb Injury | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lumbar Vertebral Fracture | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Postpericardiotomy Syndrome | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Spinal Column Injury | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Tendon Injury | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Tendon Rupture | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Tibia Fracture | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Upper Limb Fracture | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Wrist Fracture | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Investigations | ||||||
| Weight Decreased | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased Appetite | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/105 (1%) | 3/184 (1.6%) | 2/145 (1.4%) | |||
| Arthritis | 1/105 (1%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Arthropathy | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Bone Pain | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Bunion | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Chondropathy | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Foot Deformity | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Intervertebral Disc Protrusion | 0/105 (0%) | 0/184 (0%) | 2/145 (1.4%) | |||
| Joint Destruction | 0/105 (0%) | 0/184 (0%) | 2/145 (1.4%) | |||
| Lumbar Spinal Stenosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Osteoarthritis | 1/105 (1%) | 3/184 (1.6%) | 3/145 (2.1%) | |||
| Rheumatoid Arthritis | 2/105 (1.9%) | 6/184 (3.3%) | 5/145 (3.4%) | |||
| Rheumatoid Nodule | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Scoliosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Soft Tissue Necrosis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Spinal Column Stenosis | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Spondylolisthesis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Synovitis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal Cell Carcinoma | 2/105 (1.9%) | 4/184 (2.2%) | 1/145 (0.7%) | |||
| Bowen's Disease | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Breast Cancer | 1/105 (1%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Breast Cancer in Situ | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Bronchial Carcinoma | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Endometrial Cancer | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Gastric Cancer | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Haemangioma | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Lung Adenocarcinoma Metastatic | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lung Neoplasm Malignant | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lymphoma | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Lymphoproliferative Disorder | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Malignant Melanoma | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Neuroma | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Prostate Cancer | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Squamous Cell Carcinoma | 2/105 (1.9%) | 2/184 (1.1%) | 2/145 (1.4%) | |||
| Thyroid Adenoma | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Thyroid Cancer | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Uterine Leiomyoma | 1/105 (1%) | 0/184 (0%) | 3/145 (2.1%) | |||
| Nervous system disorders | ||||||
| Axonal Neuropathy | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Carotid Artery Stenosis | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Cerebrovascular Accident | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Convulsion | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Hypoaesthesia | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Lumbar Radiculopathy | 1/105 (1%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Migraine | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Paresis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Syncope | 0/105 (0%) | 2/184 (1.1%) | 1/145 (0.7%) | |||
| Psychiatric disorders | ||||||
| Suicide Attempt | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Renal and urinary disorders | ||||||
| Calculus Urinary | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Incontinence | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Nephrolithiasis | 0/105 (0%) | 2/184 (1.1%) | 1/145 (0.7%) | |||
| Nephrotic Syndrome | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Renal Failure | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Stress Urinary Incontinence | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Reproductive system and breast disorders | ||||||
| Breast Calcifications | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Breast Enlargement | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Cystocele | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Dysfunctional Uterine Bleeding | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Endometriosis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Menopausal Symptoms | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Menorrhagia | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pelvic Adhesions | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Uterine Prolapse | 0/105 (0%) | 1/184 (0.5%) | 1/145 (0.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Pulmonary Oedema | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Asthma | 1/105 (1%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Atelectasis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Chronic Obstructive Pulmonary Disease | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Haemothorax | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Interstitial Lung Disease | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Lung Disorder | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Nasal Septum Disorder | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Obstructive Airways Disorder | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Pleurisy | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Pneumonitis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Pulmonary Embolism | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Respiratory Distress | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Vocal Cord Disorder | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Vocal Cord Polyp | 1/105 (1%) | 0/184 (0%) | 0/145 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Decubitus Ulcer | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Drug Eruption | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
| Psoriasis | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Vascular disorders | ||||||
| Deep Vein Thrombosis | 0/105 (0%) | 2/184 (1.1%) | 0/145 (0%) | |||
| Hypertensive Emergency | 0/105 (0%) | 1/184 (0.5%) | 0/145 (0%) | |||
| Venous Thrombosis | 0/105 (0%) | 0/184 (0%) | 1/145 (0.7%) | |||
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 | 96/105 (91.4%) | 160/184 (87%) | 118/145 (81.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 5/105 (4.8%) | 11/184 (6%) | 7/145 (4.8%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 3/105 (2.9%) | 11/184 (6%) | 7/145 (4.8%) | |||
| Abdominal Pain Upper | 9/105 (8.6%) | 13/184 (7.1%) | 15/145 (10.3%) | |||
| Diarrhoea | 16/105 (15.2%) | 24/184 (13%) | 11/145 (7.6%) | |||
| Dyspepsia | 7/105 (6.7%) | 11/184 (6%) | 4/145 (2.8%) | |||
| Gastritis | 7/105 (6.7%) | 9/184 (4.9%) | 5/145 (3.4%) | |||
| Gastrooesophageal Reflux Disease | 5/105 (4.8%) | 6/184 (3.3%) | 8/145 (5.5%) | |||
| Nausea | 9/105 (8.6%) | 23/184 (12.5%) | 11/145 (7.6%) | |||
| General disorders | ||||||
| Fatigue | 11/105 (10.5%) | 9/184 (4.9%) | 3/145 (2.1%) | |||
| Injection Site Erythema | 4/105 (3.8%) | 20/184 (10.9%) | 3/145 (2.1%) | |||
| Oedema Peripheral | 2/105 (1.9%) | 10/184 (5.4%) | 9/145 (6.2%) | |||
| Infections and infestations | ||||||
| Bronchitis | 18/105 (17.1%) | 27/184 (14.7%) | 28/145 (19.3%) | |||
| Fungal Skin Infection | 6/105 (5.7%) | 2/184 (1.1%) | 2/145 (1.4%) | |||
| Gastroenteritis | 4/105 (3.8%) | 11/184 (6%) | 7/145 (4.8%) | |||
| Herpes Zoster | 9/105 (8.6%) | 11/184 (6%) | 10/145 (6.9%) | |||
| Influenza | 4/105 (3.8%) | 11/184 (6%) | 9/145 (6.2%) | |||
| Nasopharyngitis | 15/105 (14.3%) | 35/184 (19%) | 24/145 (16.6%) | |||
| Oral Herpes | 4/105 (3.8%) | 9/184 (4.9%) | 11/145 (7.6%) | |||
| Pharyngitis | 13/105 (12.4%) | 20/184 (10.9%) | 25/145 (17.2%) | |||
| Rhinitis | 7/105 (6.7%) | 5/184 (2.7%) | 3/145 (2.1%) | |||
| Sinusitis | 6/105 (5.7%) | 20/184 (10.9%) | 16/145 (11%) | |||
| Upper Respiratory Tract Infection | 39/105 (37.1%) | 64/184 (34.8%) | 39/145 (26.9%) | |||
| Urinary Tract Infection | 9/105 (8.6%) | 20/184 (10.9%) | 20/145 (13.8%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 5/105 (4.8%) | 13/184 (7.1%) | 8/145 (5.5%) | |||
| Investigations | ||||||
| Alanine Aminotransferase Increased | 8/105 (7.6%) | 19/184 (10.3%) | 11/145 (7.6%) | |||
| Aspartate Aminotransferase Increased | 5/105 (4.8%) | 17/184 (9.2%) | 7/145 (4.8%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 7/105 (6.7%) | 14/184 (7.6%) | 10/145 (6.9%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 16/105 (15.2%) | 18/184 (9.8%) | 15/145 (10.3%) | |||
| Back Pain | 10/105 (9.5%) | 22/184 (12%) | 20/145 (13.8%) | |||
| Musculoskeletal Pain | 4/105 (3.8%) | 10/184 (5.4%) | 7/145 (4.8%) | |||
| Osteoporosis | 4/105 (3.8%) | 10/184 (5.4%) | 4/145 (2.8%) | |||
| Pain in Extremity | 4/105 (3.8%) | 10/184 (5.4%) | 6/145 (4.1%) | |||
| Rheumatoid Arthritis | 13/105 (12.4%) | 22/184 (12%) | 15/145 (10.3%) | |||
| Nervous system disorders | ||||||
| Headache | 13/105 (12.4%) | 22/184 (12%) | 20/145 (13.8%) | |||
| Psychiatric disorders | ||||||
| Depression | 1/105 (1%) | 10/184 (5.4%) | 10/145 (6.9%) | |||
| Insomnia | 3/105 (2.9%) | 11/184 (6%) | 9/145 (6.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 24/105 (22.9%) | 35/184 (19%) | 14/145 (9.7%) | |||
| Oropharyngeal Pain | 10/105 (9.5%) | 10/184 (5.4%) | 7/145 (4.8%) | |||
| Productive Cough | 8/105 (7.6%) | 8/184 (4.3%) | 1/145 (0.7%) | |||
| Rhinorrhoea | 7/105 (6.7%) | 6/184 (3.3%) | 6/145 (4.1%) | |||
| Upper Respiratory Tract Congestion | 7/105 (6.7%) | 3/184 (1.6%) | 3/145 (2.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 6/105 (5.7%) | 6/184 (3.3%) | 4/145 (2.8%) | |||
| Rash | 3/105 (2.9%) | 19/184 (10.3%) | 15/145 (10.3%) | |||
| Skin Lesion | 8/105 (7.6%) | 6/184 (3.3%) | 2/145 (1.4%) | |||
| Vascular disorders | ||||||
| Hypertension | 8/105 (7.6%) | 25/184 (13.6%) | 21/145 (14.5%) | |||
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Director Clinical Research |
|---|---|
| Organization | Centocor Research & Development, Inc. |
| Phone | 1-800-457-6399 |
Responsible Party:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00264550
Other Study ID Numbers:
- CR006343
- C0524T06
- 2004-003296-36
First Posted:
Dec 13, 2005
Last Update Posted:
Apr 29, 2014
Last Verified:
Apr 1, 2014