A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01117129

Enrollment

Registered

2010-05-05

Start date

2010-04-30

Completion date

2010-06-30

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab \[MabThera/Rituxan\] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is \<50 patients.

Interventions

DRUGrituximab [MabThera/Rituxan]

1000 mg by i.v. infusion on day 1 and 15

DRUGplacebo

i.v. infusion on day 1 and 15

DRUGmethotrexate

10-25 mg weekly

DRUGrituximab [Mabthera/Rituxan]

1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years of age * active rheumatoid arthritis (DAS28-CRP\>3.2) * refractory to one or more anti-TNF * on stable treatment for RA for \>/=4 weeks * evidence of erosive disease and/or synovitis in wrist and/or knuckles

Exclusion criteria

* active systemic or local infection * previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia * signs of immunodeficiency, HIV infection or tuberculosis * contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent

Design outcomes

Primary

Measure	Time frame
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)	6 months

Secondary

Measure	Time frame
Bone edema score on MRI using RAMRIS	months 6, 12 and 24
Bone erosion score on MRI using RAMRIS	months 12 and 24
Synovitis score on MRI using RAMRIS	months 6, 12 and 24
Tender or swollen joint count (ACR criteria)	months 12 and 24
Health assessment questionnaire (HAQ)	months 12 and 24
Disease activity according to DAS28-CRP	months 12 and 24

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026