A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051623
• Other study ID #: CR004789
• Status: Completed
• Phase: Phase 3
• First received: January 14, 2003
• Last updated: May 16, 2011
• Start date: May 2003
• Est. completion date: June 2004

Study information

• Verified date: March 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Description:

This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis. This is an experimental medical research study. A total of 200 people in North America and Europe participated in this study during the 17 month study period. Patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (Remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintenance infusions every 8 weeks until week 46. In the placebo group, patients may early escape at week 16 and crossover at week 24 to infliximab;. In the 5mg/kg group, dose escalation if needed at week 38.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed psoriatic arthritis for >= 6 months

• active arthritis with >= 5 tender and 5 swollen joints

• active psoriasis

Exclusion Criteria:

• Have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease

• Received any systemic immunosuppressives within 4 weeks prior to enrollment in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Infliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (4)

Bortul M, Calligaris L, Moro E, Bazzocchi M, Strami G. [Preoperative transhepatic biliary drainage in the jaundiced patient: our experience]. Ann Ital Chir. 1991 May-Jun;62(3):265-71; discussion 272. Italian. — View Citation

Kavanaugh A, Antoni C, Mease P, Gladman D, Yan S, Bala M, Zhou B, Dooley LT, Beutler A, Guzzo C, Krueger GG. Effect of infliximab therapy on employment, time lost from work, and productivity in patients with psoriatic arthritis. J Rheumatol. 2006 Nov;33(1 — View Citation

Kavanaugh A, Krueger GG, Beutler A, Guzzo C, Zhou B, Dooley LT, Mease PJ, Gladman DD, de Vlam K, Geusens PP, Birbara C, Halter DG, Antoni C; IMPACT 2 Study Group. Infliximab maintains a high degree of clinical response in patients with active psoriatic ar — View Citation

van der Heijde D, Kavanaugh A, Gladman DD, Antoni C, Krueger GG, Guzzo C, Zhou B, Dooley LT, de Vlam K, Geusens P, Birbara C, Halter D, Beutler A. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with American College of Rheumatology (ACR) 20 response at week 14 Change from baseline in total radiographic scores of hands and feet at week 24
Secondary	Number of patients who achieved an ACR 20 response at wk 24; PsARC at wk 14; proportion of patients with >= to 75% Improvement From Baseline in PASI at Week 14; change from baseline SF 36 physical component summary scores at wk 14

External Links

•   |A Multicenter, Randomized, Double-blind Trial of Anti TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Subjects with Psoriatic Arthriti
•   A Multicenter, Randomized, Double-blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Subjects with Psoriatic Arthritis