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A Study of the Safety and Effectiveness of Infliximab for the Treatment of Psoriatic Arthritis
This study has been completed.
First Received: January 14, 2003   Last Updated: November 26, 2008   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00051623
  Purpose

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.


Condition Intervention Phase
Arthritis, Psoriatic
Drug: Infliximab
Phase III

Drug Information available for: Infliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: May 2003
Study Completion Date: June 2004
Detailed 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 maintanance infusions every 8 weeks until week 46. In the placebo group, paients 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051623

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications:
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(11):2254-9. Epub 2006 Sep 1.
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 arthritis through 1 year of treatment: results from the IMPACT 2 trial. Ann Rheum Dis. 2007 Apr;66(4):498-505. Epub 2006 Nov 17.
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 one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheum. 2007 Aug;56(8):2698-707.
Antoni C, Krueger GG, de Vlam K, Birbara C, Beutler A, Guzzo C, Zhou B, Dooley LT, Kavanaugh A; IMPACT 2 Trial Investigators. Infliximab improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum Dis. 2005 Aug;64(8):1150-7. Epub 2005 Jan 27.
Kavanaugh A, Antoni C, Krueger GG, Yan S, Bala M, Dooley LT, Beutler A, Guzzo C, Gladman D. Infliximab improves health related quality of life and physical function in patients with psoriatic arthritis. Ann Rheum Dis. 2006 Apr;65(4):471-7. Epub 2005 Aug 11.
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.

Study ID Numbers: CR004789
Study First Received: January 14, 2003
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00051623     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Remicade
Psoriatic arthritis
Infliximab

Study placed in the following topic categories:
Anti-Inflammatory Agents
Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Infliximab
Joint Diseases
Spondylarthropathy
Bone Diseases
Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases
Psoriasis
Arthritis
Antirheumatic Agents
Spondylarthritis
Skin Diseases, Papulosquamous
Immunoglobulins
Spondylarthropathies

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Infliximab
Joint Diseases
Gastrointestinal Agents
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Psoriasis
Therapeutic Uses
Arthritis
Antirheumatic Agents
Spondylarthritis
Skin Diseases, Papulosquamous
Dermatologic Agents
Spondylarthropathies

ClinicalTrials.gov processed this record on May 07, 2009