NCT02622503

Brief Summary

The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

5 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

April 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

December 2, 2015

Last Update Submit

December 12, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Information on previous RA treatments

    3 months

  • Information on rituximab treatment responses

    3 months

  • Information on concomitant medications

    3 months

Study Arms (1)

Patients with rheumatoid arthritis

Patients with rheumatoid arthritis receiving rituximab will be observed for treatment responses.

Drug: Rituximab

Interventions

RituximabDRUG

This is an observational study. Patients with rheumatoid arthritis and having received treatment previously will be assessed for the treatment responses.

Patients with rheumatoid arthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid arthritis (RA) patients treated with rituximab in Finland.

You may qualify if:

  • Rheumatoid arthritis (RA) patients treated with rituximab in Finland

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Helsinki, 00290, Finland

Location

Unknown Facility

Jyväskylä, 40620, Finland

Location

Unknown Facility

Lahti, 15850, Finland

Location

Unknown Facility

Tampere, 33520, Finland

Location

Unknown Facility

Turku, 20520, 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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

FI(5)