NCT02006706

Brief Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

3 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

August 10, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2007

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 6, 2014

Completed
Last Updated

August 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

December 5, 2013

Results QC Date

October 31, 2014

Last Update Submit

July 17, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

    DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

    Baseline, Week 24

Secondary Outcomes (1)

  • Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Baseline, Week 24

Study Arms (1)

MabThera/Rituxan

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

Interventions

rituximab [MabThera/Rituxan]DRUG

1000 mg iv Days 1 and 15

MabThera/Rituxan
methotrexateDRUG

10 - 25 mg/week

MabThera/Rituxan
methylprednisoloneDRUG

iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

MabThera/Rituxan

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;
  • rheumatoid arthritis after inadequate response to \>=1 DMARD treatment;
  • active disease;
  • DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

You may not qualify if:

  • autoimmune disease other than rheumatoid arthritis;
  • bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
  • concurrent treatment with any DMARD or antiTNF-alfa;
  • intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Niška Banja, 18250, Serbia

Location

Unknown Facility

Nova Sad, 21000, Serbia

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 10, 2013

Study Start

August 10, 2006

Primary Completion

November 23, 2007

Study Completion

November 23, 2007

Last Updated

August 21, 2017

Results First Posted

November 6, 2014

Record last verified: 2017-07

Locations

SE(3)