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The Clinical Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment

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ClinicalTrials.gov Identifier: NCT02837978
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Qiang Shu, Qilu Hospital of Shandong University

Brief Summary:
This study is designed to observed prospectively the efficacy and safety of 6 months treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA patients who shown insufficiency response or intolerance to DMARDs

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Tacrolimus Drug: MTX Phase 4

Detailed Description:
This study will enroll 100 cases of refractory rheumatoid arthritis (RA) patients in Chinese,who are in moderate or severe disease activity and insufficiency response or intolerance to DMARDs. The participants plan to be treated with Tacrolimus alone, or along with methotrexate (MTX) if participants were tolerant to MTX. The efficacy and safety of 6 month Tacrolimus treatment in RA patients will be evaluated with DAS28 and other disease activity indices.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Tacrolimus group
RA patients treated with tacrolimus, without MTX
Drug: Tacrolimus
Tacrolimus capsule: 0.5mg to 1mg, po, twice per day (Bid) until the endpoint or unacceptable toxicity develops.
Other Name: FK506

Active Comparator: Tacrolimus + MTX group
RA patients treated with tacrolimus and MTX
Drug: Tacrolimus
Tacrolimus capsule: 0.5mg to 1mg, po, twice per day (Bid) until the endpoint or unacceptable toxicity develops.
Other Name: FK506

Drug: MTX
MTX: 7.5mg to 15mg, po, once per week (Qw) until the endpoint or unacceptable toxicity develops.
Other Name: methotrexate




Primary Outcome Measures :
  1. Change from baseline Disease Activity Score 28 (DAS28) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline Disease Activity Score 28 (DAS28) at 24 weeks


Secondary Outcome Measures :
  1. Change from baseline ACR20 response rate at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline ACR20 response rate at 24 weeks

  2. Change from baseline Clinical disease activity index (CDAI) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline Clinical disease activity index (CDAI) at 24 weeks

  3. Change from baseline Simplified Disease Activity Index (SDAI) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline Simplified Disease Activity Index (SDAI) at 24 weeks

  4. Change from baseline Erythrocyte Sedimentation Rate (ESR) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline Erythrocyte Sedimentation Rate (ESR) at 24 weeks

  5. Change from baseline C-Reactive Protein (CRP) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline C-Reactive Protein (CRP) at 24 weeks

  6. Change from baseline swollen joint number (SW28) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline swollen joint number (SW28) at 24 weeks. SW28 means the number of joints with swelling counted in 28 synovial joints, including proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2) and knees (2) bilateral.

  7. Change from baseline tenderness joint number (T28) at 24 weeks. [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline tenderness joint number (T28) at 24 weeks. T28 means the number of joints with tenderness upon touching counted in 28 synovial joints, including proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2) and knees (2) bilateral.

  8. Change from baseline Health Assessment Questionnaire (HAQ) at 24 weeks [ Time Frame: Baseline, 12 weeks, 24weeks ]
    Change from baseline Health Assessment Questionnaire (HAQ) at 24 weeks



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis
  2. Age ≥18 years;
  3. Medium or high disease activity (DAS28≥3.2);
  4. Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
  5. Patients have not been treated with any biologic drugs;
  6. Patients have a history of baseline medication with methotrexate (MTX) or other DMARDs drugs (leflunomide, hydroxychloroquine, iguratimod, sulfasalazine, tripterygium Glycosides) for 3 months, but couldn't achieve clinical remission or low disease activity; or couldn't tolerate one or more DMARDs, and DAS28≥3.2;
  7. Dose of prednisone and NSAIDs remain stable for at least one month.

Exclusion Criteria:

  1. Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
  2. Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;
  3. Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
  4. Renal insufficiency: serum Cr ≥ 176 umol / L;
  5. Pregnant or nursing women (breastfeeding) ;
  6. Patients has a history of malignancy (cure time in less than 5 years);
  7. Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
  8. Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.

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): NCT02837978


Contacts
Contact: Qiang Shu, Dr. 0086-0531-82169654 shuqiang@sdu.edu.cn
Contact: Yameng Sui 0086-0531-82169654 qlshuqiang@126.com

Locations
China, Shandong
Qilu Hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Lv, Prof.    0086-0531-82169166    qlyykyc@163.com   
Sponsors and Collaborators
Qiang Shu
Investigators
Principal Investigator: Qiang Shu, Dr. Qilu Hospital of Shandong University

Responsible Party: Qiang Shu, Chief Physician, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02837978     History of Changes
Other Study ID Numbers: Tacrolimus RA QiluH
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 12 months of study completion.

Keywords provided by Qiang Shu, Qilu Hospital of Shandong University:
Arthritis, Rheumatoid
Tacrolimus
Treatment outcome
Safety

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action