NCT00576433

Brief Summary

This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Dec 2007

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

18 active sites

Status
completed

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 Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

December 18, 2007

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • AEs, including infusion-related adverse events

    For 48 weeks after initial treatment

Secondary Outcomes (3)

  • Safety of re-treatment (AEs)

    For 24 weeks after re-treatment.

  • Laboratory parameters, vital signs.

    Throughout study

  • ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.

    For 48 weeks after initial treatment.

Study Arms (1)

1

EXPERIMENTAL
Drug: MethotrexateDrug: rituximab [MabThera/Rituxan]

Interventions

MethotrexateDRUG

As prescribed

1
rituximab [MabThera/Rituxan]DRUG

1000mg iv on days 1 and 15

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-80 years of age;
  • moderate to severe active rheumatoid arthritis;
  • inadequate response to previous or current treatment with 1 anti-TNF agent;
  • receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks.

You may not qualify if:

  • previous treatment with MabThera;
  • use of an anti-TNF alpha agent within 8 weeks of study start;
  • concurrent treatment with any DMARD other than methotrexate;
  • active infection, or history of serious recurrent or chronic infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Chelyabinsk, 454076, Russia

Location

Unknown Facility

Irkutsk, 664047, Russia

Location

Unknown Facility

Kazan', 420012, Russia

Location

Unknown Facility

Khabarovsk, 680009, Russia

Location

Unknown Facility

Khanty-Mansiysk, 628011, Russia

Location

Unknown Facility

Kursk, 305007, Russia

Location

Unknown Facility

Moscow, 115522, Russia

Location

Unknown Facility

Nizhny Novgorod, 603126, Russia

Location

Unknown Facility

Novosibirsk, 630099, Russia

Location

Unknown Facility

Novosibirsk, 630117, Russia

Location

Unknown Facility

Ryazan, 390026, Russia

Location

Unknown Facility

Saint Petersburg, 195067, Russia

Location

Unknown Facility

Tyumen, 625023, Russia

Location

Unknown Facility

Ufa, 450005, Russia

Location

Unknown Facility

Vladivostok, 690050, Russia

Location

Unknown Facility

Voronezh, 394066, Russia

Location

Unknown Facility

Yaroslavl, 150062, Russia

Location

Unknown Facility

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MethotrexateRituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

RU(18)