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Completed

NCT Number: NCT00854321

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kuopio University Hospital

Kuopio, 70211, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • active RA without response to earlier treatment

Exclusion criteria

  • contraindications to rituximab

Treatment and study plan

Rituximab

Drug

rituximab two 1000 mg intravenous infusions separated by two weeks

rituximab, observational study amon patients with active RA

Drug

two 1000 mg intravenous infusions separated by 2 weeks

Primary outcomes

  1. ACR20 ACR50 ACR70 response

    Time frame: 6 and 12 months

Secondary outcomes

  1. Duration of clinical response

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

One Centre Follow-up Study on Safety and Efficacy

Acronym: KuoRituxi1

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2009
Registry last updated
Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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