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Clinical Trials/NCT02837978
NCT02837978CompletedPhase 4

Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China

Qiang Shu1 site in 1 country150 target enrollmentStarted: January 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Change from baseline Disease Activity Score 28 (DAS28-ESR) at 24 and longer weeks.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

This study will enroll 150 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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis;
  • •Age ≥18 years;
  • •Patients have a history of DMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, iguratimod, sulfasalazine) or any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），prednisone or Chinese traditional Medicine（tripterygium Glycosides，Sinomenine）for 3 months, but couldn't achieve clinical remission， or couldn't tolerate one or more DMARDs;
  • •Medium or high disease activity (DAS28≥3.2);
  • •Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
  • •Dose of prednisone and NSAIDs remain stable for at least one month.

Exclusion Criteria

  • •Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
  • •Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;
  • •Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
  • •Renal insufficiency: serum Cr ≥ 176 umol / L;
  • •Pregnant or nursing women (breastfeeding) ；
  • •Patients has a history of malignancy (cure time in less than 5 years);
  • •Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
  • •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.

Arms & Interventions

Tacrolimus group

Experimental

RA patients treated with tacrolimus, without MTX

Intervention: Tacrolimus (Drug)

Tacrolimus + MTX group

Active Comparator

RA patients treated with tacrolimus and MTX

Intervention: Tacrolimus (Drug)

Tacrolimus + MTX group

Active Comparator

RA patients treated with tacrolimus and MTX

Intervention: MTX (Drug)

Outcomes

Primary Outcomes

Change from baseline Disease Activity Score 28 (DAS28-ESR) at 24 and longer weeks.

Time Frame: 12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week

Change from baseline Disease Activity Score 28 (DAS28) erythrocyte sedimentation rate (ESR) at 24 and longer weeks.

Secondary Outcomes

  • Clinical response was analyzed using the European League Against Rheumatism (EULAR) improvement criteria.(12 week,3 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline C-Reactive Protein (CRP) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline Simplified Disease Activity Index (SDAI) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline ACR20 response rate at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • The clinical remission rate at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline Clinical disease activity index (CDAI) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline Erythrocyte Sedimentation Rate (ESR) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline swollen joint number (SW28) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline physician global assessment(PHGA) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline tenderness joint number (T28) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Change from baseline patient global assessment(PGA) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Safety assessed by incidence of serious adverse events (SAE)(Up to 144 weeks)
  • Change from baseline Health Assessment Questionnaire (HAQ) at 24 and longer weeks.(12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week)
  • Safety assessed by Adverse Events (AEs)(Up to 144 weeks)

Investigators

Sponsor
Qiang Shu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Qiang Shu

Chief Physician

Qilu Hospital of Shandong University

Study Sites (1)

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