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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02837978
• Date of registration: 13/07/2016
• Prospective Registration: No
• Primary sponsor: Qiang Shu
• Public title: The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment
• Scientific title: Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China
• Date of first enrolment: January 2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02837978
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Qiang Shu, Dr.
• Affiliation: Qilu Hospital of Shandong University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: MTX

Drug: Tacrolimus

Primary Outcome(s)

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]

Secondary Outcome(s)

Change from baseline tenderness joint number (T28) 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 ACR20 response rate 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 C-Reactive Protein (CRP) at 24 and longer weeks. [Time Frame: 12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week]

Safety assessed by incidence of serious adverse events (SAE) [Time Frame: Up to 144 weeks]

The clinical remission rate 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 Simplified Disease Activity Index (SDAI) 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 swollen joint number (SW28) 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 Health Assessment Questionnaire (HAQ) 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 patient global assessment(PGA) at 24 and longer weeks. [Time Frame: 12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week]

Safety assessed by Adverse Events (AEs) [Time Frame: Up to 144 weeks]

Change from baseline Clinical disease activity index (CDAI) 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 Erythrocyte Sedimentation Rate (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 physician global assessment(PHGA) at 24 and longer weeks. [Time Frame: 12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week]

Clinical response was analyzed using the European League Against Rheumatism (EULAR) improvement criteria. [Time Frame: 12 week,3 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week]

Secondary ID(s)

Tacrolimus RA QiluH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors