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)
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ClinicalTrials.gov Identifier: NCT00299546 |
Recruitment Status :
Completed
First Posted : March 7, 2006
Results First Posted : September 28, 2011
Last Update Posted : February 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthritis, Rheumatoid | Drug: Placebo Biological: Golimumab 50 mg Biological: Golimumab 100 mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | February 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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Biological: Golimumab 100 mg
SC injections |
- American College of Rheumatology (ACR) 20 Response at Week 14. [ Time Frame: 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)
- American College of Rheumatology (ACR) 50 Response at Week 14 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299546

Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Responsible Party: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00299546 |
Other Study ID Numbers: |
CR006334 C0524T11 ( Other Identifier: Centocor ) |
First Posted: | March 7, 2006 Key Record Dates |
Results First Posted: | September 28, 2011 |
Last Update Posted: | February 27, 2014 |
Last Verified: | January 2014 |
Rheumatoid Arthritis Anti-TNFa agents subcutaneous injection |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Golimumab Antibodies, Monoclonal Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |