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Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Placebo

Infliximab 3 mg/kg

Infliximab 10 mg/kg

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, infliximab, methotrexate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Infliximab 3 mg/kg every 8 weeks

Infliximab 3 mg/kg every 4 weeks

Infliximab 10 mg/kg every 8 weeks

Infliximab 10 mg/kg every 4 weeks

Arm Description

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

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.

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

safety

Full Information

NCT ID

NCT00269867

First Posted

December 22, 2005

Last Updated

November 3, 2014

Sponsor

Centocor, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00269867

Brief Title

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Official Title

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

March 1997 (undefined)

Primary Completion Date

March 2000 (Actual)

Study Completion Date

March 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centocor, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, infliximab, methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

428 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Infliximab 3 mg/kg every 8 weeks

Arm Type

Experimental

Arm Description

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.

Arm Title

Infliximab 3 mg/kg every 4 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

Infliximab 10 mg/kg every 8 weeks

Arm Type

Experimental

Arm Description

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

Arm Title

Infliximab 10 mg/kg every 4 weeks

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Infliximab 3 mg/kg

Other Intervention Name(s)

anti-TNF chimeric monoclonal antibody (cA2)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Infliximab 10 mg/kg

Other Intervention Name(s)

anti-TNF chimeric monoclonal antibody (cA2)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and Week 30

Secondary Outcome Measure Information:

Title

safety

Time Frame

up to Week 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Centocor, Inc. Clinical Trial

Organizational Affiliation

Centocor, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

11096166

Citation

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.

Results Reference

result

PubMed Identifier

27696724

Citation

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.

Results Reference

derived

Learn more about this trial

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

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