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

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

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

Inclusion Criteria:

  • active RA without response to earlier treatment

Exclusion Criteria:

  • contraindications to rituximab
  Contacts and Locations
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Please refer to this study by its identifier: NCT00854321

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

Responsible Party: Oili Kaipiainen-Seppänen, Kuopio University Hospital Identifier: NCT00854321     History of Changes
Other Study ID Numbers: KuoRituxi1
Study First Received: March 2, 2009
Last Updated: March 2, 2009

Keywords provided by Kuopio University Hospital:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 27, 2017