Last updated on April 2011

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Investigational Product in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy


Brief description of study

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Investigational Product in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy

Detailed Study Description

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Investigational Product in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy

Patient Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
  • Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm
  • If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
  • Woman must not be pregnant, breastfeeding, or become pregnant during the study

Patient Exclusion Criteria:

  • Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
  • Steroid injection or intravenous (iv) infusion in the last 6 weeks
  • Use of more than 10 mg/day of oral steroids in the last 6 weeks
  • Use of biologic DMARD concurrently or recently
  • History of a serious reaction to other biological DMARDs
  • Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
  • Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
  • Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
  • Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
  • Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
  • Hepatitis or human immunodeficiency virus (HIV)
  • A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
  • Symptoms of herpes zoster or herpes simplex within the last month
  • Active or latent tuberculosis (TB)
  • Current symptoms of a serious disorder or illness
  • Use of an investigational drug within the last month

Clinical Study Identifier: TX135262

Contact Investigators or Research Sites near you

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Suzi DeFiesta

CSI Research Inc
Alpharetta, GA USA
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