Trial | NCT02837978  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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
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 Started
Jan 31
2015
Primary Completion
Sep 30
2022
Study Completion
Dec 30
2022
Last Update
Nov 18
2023

Drug Tacrolimus

Tacrolimus capsule: 0.5mg to 1mg, po, twice per day (Bid)，adjusted by its concentration in blood or due to patient response. Then may titer down until the endpoint.

  • Other names: FK506

Drug MTX

MTX：5mg to 15mg, po, once per week (Qw) until the endpoint or adjusted due to unacceptable toxicity develops.

  • Other names: methotrexate

Tacrolimus group Experimental

RA patients treated with tacrolimus, without MTX

Tacrolimus + MTX group Active Comparator

RA patients treated with tacrolimus and MTX

Criteria 

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.
No Results Posted