Rheumatoid ArthritisPhase 4NCT00291915
Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis
A Phase 4 study testing Adalimumab and Methotrexate in people with Rheumatoid Arthritis and Arthritis, run by Goupe d'Etudes et de Recherche Clinique En Rhumatologie at 1 site in France.
Trial summary
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis
- What is being tested?
- Adalimumab and Methotrexate
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- May 2004to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early Active Potentially severe arthritis
Who cannot join
- contra indication of methotrexate or anti TNF
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Cochin
Paris, 75014
Maxime DOUGADOS, md, 00 33 1 58 41 25 62, maxime.dougados@cch.aphp.fr
Martin SOUBRIER, MD, 00 33 6 81 74 78 85, msoubrier@chu-clermond ferrand.fr
About this study
Official title: Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis
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
- Conditions
- Rheumatoid Arthritis, Arthritis
- Being tested
- Adalimumab, Methotrexate
- Keywords
- early arthritis, methotrexate, adalimumab
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
MethotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score
Secondary outcomes (3)
-Radiological score
-Functional impairment ( HAQ)
-Pain (VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startMay 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Goupe d'Etudes et de Recherche Clinique En Rhumatologie
- Sponsor type
- University, hospital or other
- Investigators
- Maxime DOUGADOS, MD, Principal investigator, Hopital Cochin Paris FRance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291915
- Sponsor's protocol ID
- GUEPARD-GERCER 2122
- Status last verified
- Feb 2006
- First submitted
- 14 Feb 2006
- Last updated
- 15 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis
- ClinicalTrials.gov ID
- NCT00291915
- Acronym / sponsor ID
- GUEPARD-GERCER 2122
- Conditions
- Rheumatoid Arthritis, Arthritis
- Keywords
- early arthritis, methotrexate, adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Goupe d'Etudes et de Recherche Clinique En RhumatologieUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Mar 2007
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early Active Potentially severe arthritis
Key exclusion criteria (1 listed)
- contra indication of methotrexate or anti TNF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab | Drug | – |
| Methotrexate | Drug | – |
Primary outcome
Disease Activity Score
3 secondary outcomes
-Radiological score
-Functional impairment ( HAQ)
-Pain (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime DOUGADOS, MD principal investigator
Hopital Cochin Paris FRance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and Methotrexate in people with Rheumatoid Arthritis and Arthritis, run by Goupe d'Etudes et de Recherche Clinique En Rhumatologie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime r DOUGADOS, MD (00 33 1 58 41 25 62, maxime.dougados@cch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2006.