Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269867
First received: December 22, 2005
Last updated: November 3, 2014
Last verified: November 2014

December 22, 2005
November 3, 2014
March 1997
March 2000   (final data collection date for primary outcome measure)
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
Complete list of historical versions of study NCT00269867 on ClinicalTrials.gov Archive Site
safety [ Time Frame: up to Week 54 ] [ Designated as safety issue: Yes ]
safety
Not Provided
Not Provided
 
Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.

This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..

Patients will be treated with either infliximab or matching placebo.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Placebo
    Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
  • Drug: Infliximab 3 mg/kg
    Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
    Other Name: anti-TNF chimeric monoclonal antibody (cA2)
  • Drug: Infliximab 10 mg/kg
    Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
    Other Name: anti-TNF chimeric monoclonal antibody (cA2)
  • Placebo Comparator: Placebo
    Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
    Intervention: Drug: Placebo
  • Experimental: Infliximab 3 mg/kg every 8 weeks
    Infliximab 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
    Intervention: Drug: Infliximab 3 mg/kg
  • Experimental: Infliximab 3 mg/kg every 4 weeks
    Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
    Intervention: Drug: Infliximab 3 mg/kg
  • Experimental: Infliximab 10 mg/kg every 8 weeks
    Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
    Intervention: Drug: Infliximab 10 mg/kg
  • Experimental: Infliximab 10 mg/kg every 4 weeks
    Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
    Intervention: Drug: Infliximab 10 mg/kg
Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000 Nov 30;343(22):1594-602.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
428
March 2000
March 2000   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with active Rheumatoid Arthritis despite treatment with methotrexate
  • Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
  • Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
  • Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

  • Patients having any systemic inflammatory condition
  • Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
  • Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
  • Who have used corticosteroids within 4 weeks prior to screening
  • Having received previous administration of infliximab
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00269867
CR006259
No
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP