NCT00424502

Brief Summary

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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
20

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

July 14, 2014

Completed
Last Updated

May 9, 2016

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

January 18, 2007

Results QC Date

June 12, 2014

Last Update Submit

April 4, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Disease Activity Score Based on 28-Joint Count (DAS28)

    DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (\>)3.2 to 5.1 = moderate to high disease activity.

    Day 0 and Week 24

Secondary Outcomes (5)

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

    Day 0 and Week 24

  • Anti-cyclic Citrullinated Peptide (Anti-CCP)

    Day 0 and Week 24

  • Vascular Endothelial Growth Factor (VEGF)

    Day 0 and Week 24

  • Erythrocyte Sedimentation Rate (ESR)

    Day 0 and Week 24

  • C-Reactive Protein (CRP)

    Day 0 and Week 24

Study Arms (1)

1

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

Interventions

rituximab [MabThera/Rituxan]DRUG

1g iv on days 1 and 15

Also known as: MabThera/Rituxan
1
MethotrexateDRUG

10-25mg po/week

1

Eligibility Criteria

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

You may qualify if:

  • adult patients, \>=18 years of age;
  • diagnosed RA for \>=3 months prior to first administration of study medication;
  • inadequate response or intolerance to \>=1 anti-TNF therapies, alone or in combination with methotrexate;
  • if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for \>=2 weeks prior to start of study.

You may not qualify if:

  • other chronic inflammatory diseases;
  • use of parental corticosteroids within 4 weeks prior to screening;
  • severe heart failure, or severe, uncontrolled cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Budapest, 1023, Hungary

Location

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

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

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

January 18, 2007

First Posted

January 19, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 9, 2016

Results First Posted

July 14, 2014

Record last verified: 2016-04

Locations

HU(3)