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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854321
First Posted: March 3, 2009
Last Update Posted: March 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kuopio University Hospital
  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 ]

Secondary Outcome Measures:
  • Duration of clinical response [ Time Frame: 6 and 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 2, 2009
First Posted: March 3, 2009
Last Update Posted: March 3, 2009
Last Verified: March 2009

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
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents