Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

Plain-language summary

This study (LYRITUX) investigates the relationship between T-lymphocyte depletion and clinical response to Rituximab treatment in patients with rheumatoid arthritis (an immune disease affecting the joints). It included patients diagnosed with rheumatoid arthritis per ACR criteria. It was a Phase 3 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

University Hospital, Tours

Intervention

Rituximab

Start date

3/9/2015

Estimated completion

12/18/2019

Countries

France

Related genes

Locations

• Brest, France
• La Roche-sur-Yon, France
• Le Mans, France
• Nantes, France
• Orléans, France
• Poitiers, France
• Rouen, France
• Tours, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* RA according to the American College of Rheumatology (ACR) criteria
* Treatment with adalimumab in accordance to the SPC
* Disease modifying anti rheumatic drugs (DMARDs) stable 4 weeks before enrollment and during 16 weeks.
* Signed consent

Exclusion Criteria:

* No anti TNF-alpha failure or contraindication
* Previous adalimumab treatment
* Contraindication to adalimumab, methylprednisolone or methotrexate (when used in combination with adalimumab)
* methotrexate-naive patient
* Any hematologic disease affecting the lymphocytes (in particular lymphomas)
* Any osteo-articular disease which could interfere with the interpretation of the influence of the rituximab on RA