Clinical trial NCT01248780: Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
injection
golimumab
simponi
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2010-11-25
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

Detailed description: Golimumab is a type of tumor necrosis factor (TNF)-inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, a 50% chance to receive golimumab and a 50% chance to receive placebo. If the patient does not have an improvement in their joints at the Week 16 visit compared to when they entered the study, and are in Group 1 (placebo group), the patient will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), the patient will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and is still receiving placebo injections, because there was improvement in their joints at Week 16, the patient will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or is already receiving golimumab injections at week 24, the patient will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (e.g., blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks from randomization (Week 0) until Week 48.

Eligibility criteria: Inclusion Criteria:

- Diagnosis of rheumatoid arthritis for at least 6 months

* Be on a stable dose of methotrexate for 4 weeks
* Have at least 4 swollen and 4 tender joints

Exclusion Criteria:

* Prior exposure to biologic anti-TNFalpha agents
* Inflammatory diseases other than rheumatoid arthritis
* Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent
* History of, or ongoing, chronic or recurrent infectious disease

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14
timeFrame: Week 14
Secondary outcomes:
measure: Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)
timeFrame: Week 14
measure: American College of Rheumatology 20 Response, Using CRP, at Week 24
timeFrame: Week 24
measure: HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
city: Chengdu
country: China
city: Hefei
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Suzhou
country: China
city: Wuhan
country: China
city: Xi'An
country: China
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: