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 active rheumatoid arthritis despite treatment 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) 20 response at Week 14, and change from baseline in the Health Assessment Questionnaire (HAQ) at Week 24.
Secondary Outcomes: The secondary outcomes are change from baseline in van der Heijde-Sharp (vdH-S) score at Week24, Disease Activity Score (DAS) 28 response (using C-reactive protein) at Week14, ACR20 response at Week 24, change from baseline in HAQ at Week14.
Expected Total Enrollment:  400

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 despite treatment 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 the Health Assessment Questionnaire (HAQ), 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 RA. The HAQ is a series of questions that measure a subject''''s impairment in physical function caused by RA. Other secondary measures of effectiveness include the van der Heijde Modified Sharp (vdH-S) score, which is a measurement of the amount of joint damage in a subject as seen by x-ray.

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 screening
• Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15mg/week for at least 3 months prior to screening, and have a MTX dose of >=15mg/week and <=25mg/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 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 other than MTX, 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  NCT00264550

Study ID Numbers:  CR006343; C0525T06
Last Updated:  December 12, 2005
Record first received:  December 11, 2005
ClinicalTrials.gov Identifier:  NCT00264550
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10