The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-17010307
• Date of registration: 2017-01-01
• Prospective Registration: Yes
• Primary sponsor: the Second Hospital of Shanxi Medical University
• Public title: The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China
• Scientific title: The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China
• Date of first enrolment: 2017-01-01
• Target sample size: Rapamycin group:200;Non-rapamycin group :100;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=17245
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Xiaofeng Li
• Affiliation: The Second Hospital of Shanxi Medical University

• Name: Shengxiao Zhang
• Affiliation: The Second Hospital of Shanxi Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subject is a male or female between the age of 18 and 65 years;
2. Subject fulfills the revised the 2009 ACR/EULAR criteria for the classification of RA;
3. Active RA is defined as the presence of at least 3 swollen joints and at least 8 tender joints and morning stiffness lasting longer than 60 minutes; At least one of the following: a serum C reactive protein (CRP) level is at least 1.5 times of upper limit or an erythrocyte sedimentation rate (ESR) is at least 28 mm/hour;
4. Subject must meet the following requirements of laboratory tests:
(1) Hb >85g/L; WBC>4x10^9/L; Neutrophil>1.5x10^9/L; Platelet >100x10^9/L;
(2) Transaminase 1.5times the upper limit of normal; Creatinine>120 mol/L (1.4mg/dl);
5. Th17 level of patients must be no less than normal;
6. Subject is negative in pregnancy test and agrees to use effective contraception during the study and for at least 6 months after stopping study treatment;
7. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures;
8. Subject or subjects legal representative has signed the informed consent form.
Exclusion criteria: 1. Patients are wholly disabled and have little or no self-care ability, such as being bedridden or confined to a wheelchair;
2. Patients have a diagnosis of any systemic inflammatory disease other than RA such as SLE, which symptoms and signs are expected to affect the evaluation of experimental drugs;
3. Patients have a history of malignancy or are suffering malignant disease within 5 years prior to study entry; Have a history of chronic or severe infection within 2 months or a history of oppotunistic infection within 6 months; Have active hepatitis or suffer from the infection of hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Have a history of lymphoproliferative disease; Have multiple sclerosis or demyelinating disease of central nervous system; Have experienced or are experiencing congestive heart failure; Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; Protein purified derivative (PPD) test is positive, or ( and ) X - ray film showed signs of lung infection or have close contact with patients with tuberculosis (TB);
4. Patients were recruited to other clinical trial(s) involving an investigational medicinal product or are currently receiving or have received biological agents therapy within 4 weeks prior to study entry5.Patients are allergic to the drug compounds.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

M05.901

Intervention(s)

Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;

Primary Outcome(s)

peripheral blood lymphocyte subsets;CD4+T subgroups;Efficacy endpoint;safety measures;

Secondary Outcome(s)

Vital signs (temperature, resting heart rate, breathing, blood pressure);

Source(s) of Monetary Support

Self support