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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02304354
• Date of registration: 04/11/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Tours
• Public title: Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX) LYRITUX
• Scientific title: Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)
• Date of first enrolment: March 9, 2015
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02304354
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Denis MULLEMAN, MD-PhD
• Affiliation: CHRU de TOURS

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

T-lymphocyte count [Time Frame: up to week 48]

DAS28 [Time Frame: up week 48]

Secondary Outcome(s)

Immunoglobulines G [Time Frame: Baseline up to 48 weeks]

C reactive Protein (CRP) [Time Frame: Baseline up to 48 weeks]

Cytokine profile [Time Frame: Baseline up to 48 weeks]

Metabolomic profil [Time Frame: Baseline up to 16 weeks]

Pharmacokinetics (Systemic Clearance and central volume of distribution) [Time Frame: Baseline up to 48 weeks]

RNA [Time Frame: Baseline]

FCGR3A 156 F/V gene polymorphism [Time Frame: Baseline]

Occurrence of infections [Time Frame: Baseline up to 48 weeks]

Secondary ID(s)

2014-000859-91

140896A-32

2014-R24

PHRI13-JM/LYRITUX

Source(s) of Monetary Support

Please refer to primary and secondary sponsors