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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01117129
First received: May 4, 2010
Last updated: January 18, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: rituximab [MabThera/Rituxan]
Drug: placebo
Drug: methotrexate
Drug: rituximab [Mabthera/Rituxan]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Synovitis score on MRI using RAMRIS [ Time Frame: months 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Bone edema score on MRI using RAMRIS [ Time Frame: months 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Bone erosion score on MRI using RAMRIS [ Time Frame: months 12 and 24 ] [ Designated as safety issue: No ]
  • Disease activity according to DAS28-CRP [ Time Frame: months 12 and 24 ] [ Designated as safety issue: No ]
  • Tender or swollen joint count (ACR criteria) [ Time Frame: months 12 and 24 ] [ Designated as safety issue: No ]
  • Health assessment questionnaire (HAQ) [ Time Frame: months 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Completion Date: September 2010
Arms Assigned Interventions
Experimental: A Drug: rituximab [MabThera/Rituxan]
1000 mg by i.v. infusion on day 1 and 15
Drug: methotrexate
10-25 mg weekly
Drug: rituximab [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
Placebo Comparator: B Drug: placebo
i.v. infusion on day 1 and 15
Drug: methotrexate
10-25 mg weekly
Drug: rituximab [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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117129

Locations
Spain
Barcelona, Spain, 08003
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01117129     History of Changes
Other Study ID Numbers: ML21826, 2008-002381-55
Study First Received: May 4, 2010
Last Updated: January 18, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013