A double-blind, placebo-controlled study of anti-CD5 immunoconjugate in patients with rheumatoid arthritis. The Xoma RA Investigator Group

Arthritis Rheum. 1996 Jul;39(7):1102-8. doi: 10.1002/art.1780390705.

Abstract

Objective: To evaluate the efficacy of an anti-CD5 ricin-linked immunoconjugate (CD5-IC) in patients with rheumatoid arthritis (RA).

Methods: A total of 104 evaluable patients were enrolled in a multicenter, double-blind, multiple-dose, placebo-controlled study of CD5-IC.

Results: Treatment with CD5-IC in doses up to 8 mg/m2/day for 4 days in 1 month failed to produce marked or prolonged T cell depletion and was no more effective than placebo in ameliorating disease manifestations. An unexpectedly high placebo response was observed in 48% of the patients. Adverse events were correlated with the dose of CD5-IC, but the treatment was generally well-tolerated.

Conclusion: At the doses used in this study, CD5-IC was ineffective for treating RA.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Arthritis, Rheumatoid / complications
  • Arthritis, Rheumatoid / immunology
  • Arthritis, Rheumatoid / therapy*
  • CD5 Antigens / administration & dosage
  • CD5 Antigens / adverse effects
  • CD5 Antigens / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Humans
  • Immunoconjugates / administration & dosage
  • Immunoconjugates / adverse effects
  • Immunoconjugates / therapeutic use*
  • Lymphocyte Depletion
  • Middle Aged
  • Ricin
  • Time Factors
  • Treatment Outcome

Substances

  • CD5 Antigens
  • Immunoconjugates
  • Ricin