NCT01075477

Brief Summary

This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

8 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

September 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

February 24, 2010

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy: DAS28

    29 months

Secondary Outcomes (2)

  • Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)

    29 months

  • Safety: serious and non-serious adverse events

    29 months

Study Arms (1)

Cohort

Drug: rituximab [Mabthera/Rituxan]

Interventions

rituximab [Mabthera/Rituxan]DRUG

As prescribed by physician

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rheumatoid arthritis on or commencing treatment with rituximab \[MabThera\]

You may qualify if:

  • adult patients, \>/= 18 years of age
  • rheumatoid arthritis
  • treatment with rituximab

You may not qualify if:

  • unable/unwilling to give informed consent to data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Hämeenlinna, 13530, Finland

Location

Unknown Facility

Helsinki, 00290, Finland

Location

Unknown Facility

Joensuu, 80210, Finland

Location

Unknown Facility

Jyväskylä, 40620, Finland

Location

Unknown Facility

Paimio, 21540, Finland

Location

Unknown Facility

Riihimäki, 11101, Finland

Location

Unknown Facility

Seinäjoki, 60220, Finland

Location

Unknown Facility

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

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 GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 25, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FI(8)