NCT00291915

Brief Summary

Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 15, 2006

Status Verified

February 1, 2006

First QC Date

February 14, 2006

Last Update Submit

February 14, 2006

Conditions

Rheumatoid ArthritisArthritis

Keywords

early arthritis, methotrexate, adalimumab

Outcome Measures

Primary Outcomes (1)

  • Disease Activity Score

Secondary Outcomes (3)

  • -Radiological score

  • -Functional impairment ( HAQ)

  • -Pain (VAS)

Interventions

AdalimumabDRUG
MethotrexateDRUG

Eligibility Criteria

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

You may qualify if:

  • Early Active Potentially severe arthritis

You may not qualify if:

  • contra indication of methotrexate or anti TNF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

AdalimumabMethotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Maxime DOUGADOS, MD

    Hopital Cochin Paris FRance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime r DOUGADOS, MD

CONTACT

00 33 1 58 41 25 62maxime.dougados@cch.aphp.fr

Martin SOUBRIER, MD

CONTACT

00 33 6 81 74 78 85msoubrier@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

May 1, 2004

Study Completion

March 1, 2007

Last Updated

February 15, 2006

Record last verified: 2006-02

Locations

FR(1)