NCT01000610

Brief Summary

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Mar 2008

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

4 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

March 17, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 19, 2015

Completed
Last Updated

August 16, 2017

Status Verified

June 1, 2017

Enrollment Period

4.2 years

First QC Date

October 21, 2009

Results QC Date

February 27, 2015

Last Update Submit

July 7, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Adverse Events (AEs)

    Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Secondary Outcomes (3)

  • Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24

    Baseline and Week 24

  • Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24

    Baseline and Week 24

  • Change in Bone Density (in Participants Untreated With Bisphosphonates)

    Screening and Week 84

Study Arms (1)

single arm

EXPERIMENTAL
Drug: rituximab [MabThera/Rituxan]Drug: methotrexateDrug: methylprednisolone

Interventions

rituximab [MabThera/Rituxan]DRUG

1000 mg iv infusion on days 1 and 15

single arm
methotrexateDRUG

10-25 mg weekly (oral or parenteral)

single arm
methylprednisoloneDRUG

100 mg iv prior to each rituximab infusion

single arm

Eligibility Criteria

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

You may qualify if:

  • adult patients \>/= 18 years of age
  • rheumatoid arthritis DAS28 \>/= 3.2
  • receiving treatment on an outpatient basis
  • experienced an inadequate response to previous or current treatment with methotrexate

You may not qualify if:

  • rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • history of or current inflammatory joint disease other than RA
  • previous treatment with any cell-depleting therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Farhat Hached; Service Rhumatologie

Sousse, 4000, Tunisia

Location

Hopital Charles Nicole; Service Rhumatologie

Tunis, 1006, Tunisia

Location

Hopital La Rabta; Service Rhumatologie

Tunis, 1007, Tunisia

Location

Hopital Mongi Slim; Service Rhumatologie

Tunis, 2046, Tunisia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

RituximabMethotrexateMethylprednisolone

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 CompoundsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann- LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

March 17, 2008

Primary Completion

May 16, 2012

Study Completion

May 16, 2012

Last Updated

August 16, 2017

Results First Posted

March 19, 2015

Record last verified: 2017-06

Locations

TU(4)