The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: golimumab (CNTO 148)	Phase III

Further study details as provided by Centocor, Inc.:

Primary Outcomes: The primary outcomes are American College of Rheumatology (ACR) 50 response at Week 24, and the change from baseline in van der Heijde Modified Sharp (vdH-S) score at Week 52.
Secondary Outcomes: The secondary outcomes are change from baseline in HAQ at Week52, ACR20 response at Week24, change from baseline in vdH-S score at Week52 in subjects with abnormal CRP at baseline, and ACR50 response at Week24 in subjects with abnormal CRP at baseline.
Expected Total Enrollment:  600

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFα). TNFα 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 TNFα (anti-TNFα 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-TNFα drug, golimumab, at 2 doses, injected under the skin every 4 weeks, alone or in combination with methotrexate, compared with methotrexate alone, in subjects with active RA who have not been previously treated with methotrexate. The study hypothesis is that golimumab, alone or in combination with methotrexate, will be more effective in treatment of RA than methotrexate alone, as measured by the American College of Rheumatology (ACR) response criteria and change from baseline in van der Heijde Modified Sharp (vdH-S) score, without causing unacceptable significant adverse effects. The ACR response criteria were designed to determine the percentage of subjects who have achieved a certain level of improvement in their signs and symptoms of rheumatoid arthritis. The vdH-S score is a measurement of the amount of joint damage in a subject as seen by x-ray. Other secondary measures of effectiveness include the Health Assessment Questionnaire (HAQ), which is a series of questions that measure a subject''''s impairment in physical function caused by RA.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 first administration of study agent;
• Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time);

• 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 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:

• Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy;
• No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent;
• No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)
• No history of, or ongoing, chronic or recurrent infectious disease
• No serious infection within 2 months prior to first administration of study agent.

Please refer to this study by ClinicalTrials.gov identifier  NCT00264537

Study ID Numbers:  CR006331; C0524T05
Last Updated:  December 12, 2005
Record first received:  December 11, 2005
ClinicalTrials.gov Identifier:  NCT00264537
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10