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

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ClinicalTrials.gov Identifier: NCT00854321
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : March 3, 2009
Sponsor:
Information provided by:
Kuopio University Hospital

Brief Summary:
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 or disease Intervention/treatment
Rheumatoid Arthritis Drug: rituximab Drug: rituximab, observational study amon patients with active RA

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

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: One Centre Follow-up Study on Safety and Efficacy
Study Start Date : November 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. ACR20 ACR50 ACR70 response [ Time Frame: 6 and 12 months ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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Study Director: Oili Kaipiainen-Seppänen, MD Kuopio University Hospital
Publications:
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Responsible Party: Oili Kaipiainen-Seppänen, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00854321    
Other Study ID Numbers: KuoRituxi1
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009
Keywords provided by Kuopio University Hospital:
rheumatoid arthritis
rituximab
therapy
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents