The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment

NCT ID: NCT02837978

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-12-30

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus group

RA patients treated with tacrolimus, without MTX

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

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.

Tacrolimus + MTX group

RA patients treated with tacrolimus and MTX

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

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.

MTX

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

MTX

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

Intervention Type: DRUG

Other Intervention Names

FK506; methotrexate

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis;

2. Age ≥18 years;

3. 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;

4. Medium or high disease activity (DAS28≥3.2);

5. Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qiang Shu

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qiang Shu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

Tacrolimus RA QiluH

Identifier Type: -

Identifier Source: org_study_id