Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital (KuoRituxi1)

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00854321
First received: March 2, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.


Condition Intervention
Rheumatoid Arthritis
Drug: rituximab
Drug: rituximab, observational study amon patients with active RA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: One Centre Follow-up Study on Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • ACR20 ACR50 ACR70 response [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of clinical response [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with active RA
drug, follow-up
Drug: rituximab
rituximab two 1000 mg intravenous infusions separated by two weeks
Drug: rituximab, observational study amon patients with active RA
two 1000 mg intravenous infusions separated by 2 weeks

Detailed Description:

Data is collected on regular visits in the outpatient department. In collection national register forms have been used.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with active RA in one centre

Criteria

Inclusion Criteria:

  • active RA without response to earlier treatment

Exclusion Criteria:

  • contraindications to rituximab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854321

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Oili Kaipiainen-Seppänen, MD Kuopio University Hospital
  More Information

Publications:
Responsible Party: Oili Kaipiainen-Seppänen, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00854321     History of Changes
Other Study ID Numbers: KuoRituxi1
Study First Received: March 2, 2009
Last Updated: March 2, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
rheumatoid arthritis
rituximab
therapy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014