NCT01117129

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

May 4, 2010

Last Update Submit

March 27, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)

    6 months

Secondary Outcomes (6)

  • Synovitis score on MRI using RAMRIS

    months 6, 12 and 24

  • Bone edema score on MRI using RAMRIS

    months 6, 12 and 24

  • Bone erosion score on MRI using RAMRIS

    months 12 and 24

  • Disease activity according to DAS28-CRP

    months 12 and 24

  • Tender or swollen joint count (ACR criteria)

    months 12 and 24

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: rituximab [MabThera/Rituxan]Drug: methotrexate

B

PLACEBO COMPARATOR
Drug: placeboDrug: methotrexateDrug: rituximab [Mabthera/Rituxan]

Interventions

rituximab [Mabthera/Rituxan]DRUG

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

A
placeboDRUG

i.v. infusion on day 1 and 15

B
methotrexateDRUG

10-25 mg weekly

AB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

RituximabMethotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

ES(1)