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Status unknownNCT00291915Updated Feb 15, 2006

Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

A Phase 4 interventional study of Adalimumab and Methotrexate in Rheumatoid Arthritis and Arthritis, sponsored by Goupe d'Etudes et de Recherche Clinique En Rhumatologie. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-15.

Sponsored by Goupe d'Etudes et de Recherche Clinique En Rhumatologie · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months

02

Conditions studied

  • Rheumatoid Arthritis
  • Arthritis

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Keywords

  • early arthritis, methotrexate, adalimumab
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with Goupe d'Etudes et de Recherche Clinique En Rhumatologie as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Early Active Potentially severe arthritis

Exclusion criteria

Exclusion Criteria:

  • contra indication of methotrexate or anti TNF
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants

Interventions

  • DrugAdalimumab
  • DrugMethotrexate
06

What researchers measure

Primary outcomes

  1. Disease Activity Score

Secondary outcomes

  1. -Radiological score

  2. -Functional impairment ( HAQ)

  3. -Pain (VAS)

07

Study locations

1 of 1 sites recruiting
  • Hopital Cochin
    Paris, 75014, France
    • Maxime DOUGADOS, md · Contact · maxime.dougados@cch.aphp.fr · 00 33 1 58 41 25 62
    • Martin SOUBRIER, MD · Contact · msoubrier@chu-clermond ferrand.fr · 00 33 6 81 74 78 85
    • maxime DOUGADOS, MD · Principal investigator
    • Martin SOUBRIER · Sub investigator
    • Bernard COMBE, MD · Sub investigator
    • Jean SIBILIA, MD · Sub investigator
    • Olivier MEYER, MD · Sub investigator
    • Xavier PUECHAL, MD · Sub investigator
    • Françis BERENBAUM, PhD · Sub investigator
    • Xavier MARIETTE, MD · Sub investigator
    • Patrice FARDELLONE, MD · Sub investigator
    • René Marc FLIPO, MD · Sub investigator
    • Philippe GOUPILLE, PhD · Sub investigator
    • Thierry SCHAEVERBEKE, PhD · Sub investigator
    • C ZARNITSKY, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00291915
Lead sponsor
Goupe d'Etudes et de Recherche Clinique En Rhumatologie
First posted
Feb 15, 2006
Start date
May 2004
Completion
Mar 2007
Last update
Feb 15, 2006

Study contacts

Maxime r DOUGADOS, MD
Contact
maxime.dougados@cch.aphp.fr
00 33 1 58 41 25 62
Martin SOUBRIER, MD
Contact
msoubrier@chu-clermontferrand.fr
00 33 6 81 74 78 85
Maxime DOUGADOS, MD
principal investigator · Hopital Cochin Paris FRance
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

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