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OpenTrials
Completed

NCT Number: NCT00077870

A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
  • Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
  • Positive serum RF
  • Current treatment for RA on an outpatient basis
  • Contact your local site that is listed for more inclusion criteria

Exclusion criteria

  • Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
  • Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
  • Functional Class IV as defined by the ACR classification of functional status in RA
  • History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
  • Contact your local site that is listed for more exclusion criteria

Treatment and study plan

Ocrelizumab

Drug

Primary outcomes

  1. Safety and tolerability of ocrelizumab in subjects with moderate to severe RA

Secondary outcomes

  1. Pharmacokinetics of ocrelizumab

  2. Pharmacodynamics of ocrelizumab

  3. Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate

Important dates

Study start
2004
Study completion
2006
First posted
Feb 16, 2004
Registry last updated
Sep 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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