A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

Key facts

Study ID

NCT01007435

Run by

Hoffmann-La Roche

People needed

1162

Starts

2009-10-31

Expected to finish

2014-01-28

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients ≥ 18 years of age.
• Rheumatoid arthritis of ≤ 2 years duration.
• Disease Activity Score 28 (DAS28) > 3.2.
• Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
• Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening).
• Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.

You may not qualify if…

• Previous treatment with tocilizumab.
• Previous treatment with methotrexate or biologic agent.
• Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
• History of or current inflammatory joint disease other than RA.
• Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Clnical & Translational Reseach Center for Alabama, PC — Tuscaloosa, Alabama, United States
• Arthrocare, Arthritis Care and Research, P.C. — Mesa, Arizona, United States
• Sun Valley Arthritis Center — Peoria, Arizona, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Uni of California - San Diego; Division of Rheumatology — La Jolla, California, United States
• Valerius Medical Group & Research Ctr of Greater Long Beach — Los Alamitos, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• San Diego Arthritis Med Clnc — San Diego, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Joao Nascimento — Bridgeport, Connecticut, United States
• New England Research Associates — Trumbull, Connecticut, United States
• Arthritis/Osteoporosis Treatment Center — Orange Park, Florida, United States
• Arthritis Center Palm Harbor — Palm Harbor, Florida, United States
• Arthritis Rsrch of Florida, Inc. — Palm Harbor, Florida, United States
• Burnette & Silverfield, MDS — Tampa, Florida, United States
• Quad City Rheumatology, Sc — Moline, Illinois, United States
• Illinois Bone & Joint Inst. — Morton Grove, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Deerbrook Medical Associates — Vernon Hills, Illinois, United States
• Physician'S Clinic of Iowa — Cedar Rapids, Iowa, United States
• Via Christi Clinic, PA — Wichita, Kansas, United States
• Baton Rouge Clinic, Amc — Baton Rouge, Louisiana, United States
• Osteoporosis & Clinical Trials Center — Cumberland, Maryland, United States
• Pinnacle Research Group; Llc, Central — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.