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

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291915

Enrollment

Registered

2006-02-15

Start date

2004-05-31

Completion date

2007-03-31

Last updated

2006-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid Arthritis

Keywords

early arthritis, methotrexate, adalimumab

Brief summary

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

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

Interventions

DRUGAdalimumab

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Early Active Potentially severe arthritis

Exclusion criteria

* contra indication of methotrexate or anti TNF

Design outcomes

Primary

Measure	Time frame
Disease Activity Score	—

Secondary

Measure	Time frame
-Radiological score	—
-Functional impairment ( HAQ)	—
-Pain (VAS)	—

Countries

France

Contacts

Primary ContactMaxime r DOUGADOS, MD

maxime.dougados@cch.aphp.fr00 33 1 58 41 25 62

Backup ContactMartin SOUBRIER, MD

msoubrier@chu-clermontferrand.fr00 33 6 81 74 78 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026