NCT06933134

Brief Summary

Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
31mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

March 25, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

March 25, 2025

Last Update Submit

April 29, 2026

Conditions

Rheumatoid Arthritis (RA)

Keywords

pharmacological biomarkerrituximabretreatmentlow dose

Outcome Measures

Primary Outcomes (2)

  • Observed Disease Activity Score(DAS) 28-CRP

    DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab

    6 months after a second low-dose cycle

  • Calculated DAS28-CRP

    DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count

    6 months after a second low-dose cycle

Secondary Outcomes (5)

  • Prevalence observed DAS28-CRP

    3 months and 6 months of the first and second cycle of low-dose rituximab

  • Description of events

    From enrolment to 12 months

  • prevalence calculated DAS28-CRP

    6 months of the second cycle of low-dose rituximab

  • CD4 T cell count

    6 months of a second cycle of low dose rituximab.

  • immunoglobulin G level

    6 months of a second cycle of low dose rituximab.

Study Arms (1)

Patients group

The number of subjects required for our study was set at 30. It's a single-centre prospective non-interventional descriptive study. Patients will be followed every 3 months during 12 months. At inclusion, they will receive a first cycle of low-dose rituximab followed by a second cycle at 6 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with a diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria on standard-dose rituximab with a good clinical response.

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
  • Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
  • In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
  • If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.

You may not qualify if:

  • Other associated targeted disease-modifying therapy
  • Sjögren's syndrome or other associated inflammatory rheumatism
  • Fibromyalgia or other pathology having an impact on the assessment of disease activity
  • Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
  • Opposition to data processing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 blood samples at months 0, 3, 6, 9 and 12

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Simon BRUNET

CONTACT

247475917simon.brunet@chu-tours.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 18, 2025

Study Start

April 23, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

FR(1)