NCT00244556

Brief Summary

To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_4 rheumatoid-arthritis

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

March 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

October 12, 2005

Last Update Submit

February 20, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.

Secondary Outcomes (1)

  • To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.

Interventions

Methotrexate plus ENBREL or ENBREL aloneDRUG

Eligibility Criteria

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

You may qualify if:

  • In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MethotrexateEtanercept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 26, 2005

Study Start

March 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

February 21, 2013

Record last verified: 2013-02