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Completed

NCT Number: NCT01870908

Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Chūbu, Japan

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About this study

The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI < 3.3)

Treatment and study plan

Tacrolimus

Drug

Other names: prograf

biological agents

Drug

Primary outcomes

  1. Simplified disease activity index (SDAI)

    Time frame: Baseline and week-24

Secondary outcomes

  1. Clinical disease activity index (CDAI)

    Time frame: Baseline, week-12 and week-24

  2. Disease Activity Score 28 (DAS28)

    Time frame: Baseline, week-12 and week-24

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Oct 5, 2015

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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