Multicenter Randomized Prospective Trial Comparing Methot... | NCT00291915

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

NCT00291915

Sponsor

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

Status

Unknown status

Last Update Posted

Feb 15, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Rheumatoid Arthritis
Arthritis

Interventions

Adalimumab
Methotrexate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2006

Last Update Posted Date

Feb 15, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Goupe d'Etudes et de Recherche Clinique En RhumatologieOTHER

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Disease Activity Score

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Early Active Potentially severe arthritis

Exclusion Criteria:

contra indication of methotrexate or anti TNF

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maxime r DOUGADOS, MD	Contact	00 33 1 58 41 25 62		maxime.dougados@cch.aphp.fr
Martin SOUBRIER, MD	Contact	00 33 6 81 74 78 85		msoubrier@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Maxime DOUGADOS, MD	Hopital Cochin Paris FRance	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Cochin	Recruiting	Paris		75014	France

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab
D008727	Methotrexate

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Drug
Methotrexate	Drug

Measure	Description	Time Frame
-Radiological score
-Functional impairment ( HAQ)
-Pain (VAS)