A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.

F. Hoffmann La-Roche AG0 sites1,200 target enrollmentMarch 10, 2005

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: F. Hoffmann La-Roche AG
Enrollment: 1200
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 10, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann La-Roche AG

Eligibility Criteria

Inclusion Criteria

•1\.Able and willing to give written informed consent and comply with the requirements of the study protocol.
•2\.Patients with rheumatoid arthritis of ³ 6 months duration diagnosed according to the revised 1987 American College of Rheumatology (ACR; formerly American Rheumatism Association) criteria (Appendix 2\).
•3\.Receiving treatment on an outpatient basis.
•4\.Prior to randomization, will have discontinued etanercept for ³ 2 weeks, infliximab or adalimumab for ³ 8 weeks (see exclusion \# 5\), anakinra for ³ 1 week.
•5\.Have received permitted DMARDs, each at a stable dose, for at least 8 weeks prior to baseline.
•6\.Swollen joint count (SJC) ³ 6 (66 joint count) and tender joint count (TJC) ³ 8 (68 joint count) at screening and baseline.
•7\.At screening either CRP ³ 1 mg/dL (10 mg/L) or ESR ³ 28 mm/hr
•8\.Age ³ 18 years
•9\.Oral corticosteroids (£ 10 mg/day prednisone or equivalent) and NSAIDs (up to the maximum recommended dose) are permitted if the dose has been stable for at least 6 weeks prior to baseline.
•10\.Females of child\-bearing potential and males with female partners of child\-bearing potential may participate in this trial only if using a reliable means of contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD).

Exclusion Criteria

•1\.Major surgery (including joint surgery) within eight weeks prior to screening or planned surgery within six months following randomization.
•2\.Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren’s Syndrome with RA is allowable.
•3\.Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
•4\.Prior history of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease).
•Excluded Previous or Concomitant Therapy:
•5\.Unsuccessful treatment with an anti\-TNF agent (i.e. significant safety issues or lack of efficacy; Patients who terminated previous anti\-TNF treatment due to cost or discomfort with the subcutaneous injections, may participate in this study.) (See Inclusion \#4 for anti\-TNF agent washouts.)
•6\.Treatment with any investigational agent within four weeks (or five half\-lives, whichever is longer) of screening.
•7\.Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti\-CD4, anti\-CD5, anti\-CD3, anti\-CD19 and anti\-CD20\).
•8\.Treatment with intravenous gamma globulin, plasmapheresis or Prosorba ä column within six months of baseline.
•9\.Intra\-articular or parenteral corticosteroids within six weeks prior to baseline.