NCT00246064

Brief Summary

The purpose of the study was to evaluate the ability of a maintenance dosage regimen of infliximab to achieve and sustain at least 40% improvement from baseline in the total joint count in patients with active Rheumatoid Arthritis (RA) during methotrexate tapering.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
Last Updated

May 19, 2011

Status Verified

January 1, 2011

First QC Date

October 28, 2005

Last Update Submit

May 18, 2011

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid ArthritisInfliximab infusionsMethotrexateRemicade

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint is the number (%) of patients on a maintenance dose of infliximab who achieve at least 40% improvement from baseline in the combined tender and swollen joint count and tolerate any reduction in MTX dose at Week 54

Secondary Outcomes (1)

  • Sustained improvement in signs and symptoms of RA at Week 54, as measured by the percentage improvement from baseline in ACR20 score. Improvement of the ACR20 core set components at Week 54.

Interventions

infliximabDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al., 1988)
  • patients must have a minimum of 8 tender and 4 swollen joints with disease diagnosed at least 3 months prior to screening
  • patients must have been using oral or parenteral MTX for at least the previous 3 months, and at a stable dose of 7.5 to 25 mg per week for at least the previous 1 month
  • women of childbearing potential must test negative for pregnancy and be using adequate birth control measures
  • patients must have a documented purified protein derivative (PPD) skin test performed at prescreening.

You may not qualify if:

  • Patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) (e.g., etanercept, pentoxifylline or thalidomide) within the previous 3 months
  • patients who are incapacitated
  • history of infected joint prosthesis within the previous 5 years
  • patients with a concomitant diagnosis of congestive heart failure (CHF), history of or known malignancy within the previous 5 years, cases of active or latent tuberculosis (TB), acute or chronic serious infections within the past 3 months
  • known substance abuse (drug or alcohol) within the previous 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fleischmann RM, Cohen SB, Moreland LW, Schiff M, Mease PJ, Smith DB, Keenan G, Kremer JM; iRAMT Study Group. Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab: the Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) trial. Curr Med Res Opin. 2005 Aug;21(8):1181-90. doi: 10.1185/030079905X53261.

    PMID: 16083527RESULT

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Centocor Ortho Biotech Services, L.L.C. Clinical Trial

    Centocor Ortho Biotech Services, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

December 1, 2001

Study Completion

November 1, 2003

Last Updated

May 19, 2011

Record last verified: 2011-01