Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

NCT00269867 | Completed Phase 3

• 1 other identifier: CR006259
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; infliximab; methotrexate

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score

  Baseline and Week 30

Secondary Outcomes (1)

• safety

  up to Week 54

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.

Drug: Placebo

Infliximab 3 mg/kg every 8 weeks

EXPERIMENTAL

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.

Drug: Infliximab 3 mg/kg

Infliximab 3 mg/kg every 4 weeks

EXPERIMENTAL

Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.

Drug: Infliximab 3 mg/kg

Infliximab 10 mg/kg every 8 weeks

EXPERIMENTAL

Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.

Drug: Infliximab 10 mg/kg

Infliximab 10 mg/kg every 4 weeks

EXPERIMENTAL

Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.

Drug: Infliximab 10 mg/kg

Interventions

Placebo DRUG

Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.

Placebo

Infliximab 3 mg/kg DRUG

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.

Also known as: anti-TNF chimeric monoclonal antibody (cA2)

Infliximab 3 mg/kg every 4 weeks; Infliximab 3 mg/kg every 8 weeks

Infliximab 10 mg/kg DRUG

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.

Also known as: anti-TNF chimeric monoclonal antibody (cA2)

Infliximab 10 mg/kg every 4 weeks; Infliximab 10 mg/kg every 8 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (2)

• 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. doi: 10.1056/NEJM200011303432202.

  PMID: 11096166 RESULT

• Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945.

  PMID: 27696724 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: March 1, 1997
• Primary Completion: March 1, 2000
• Study Completion: March 1, 2000
• Last Updated: November 4, 2014

Record last verified: 2014-11