The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-INR-16009546
• Date of registration: 2016-10-21
• Prospective Registration: Yes
• Primary sponsor: the Second Hospital of Shanxi Medical University
• Public title: The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis
• Scientific title: The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis
• Date of first enrolment: 2016-11-01
• Target sample size: IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13909
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

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. Male or female aged 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;
4. 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;
5. Subject must meet the following requirements of laboratory tests:
(1) Hb85g/LWBC4*10^9/L; Neutrophil 1.5*10^9/L; Platelet 10*10^9/L;
(2) Transaminase 1.5 times the upper limit of normal Creatinine 120mol/L (1.4mg/dl);
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 entry;
5. 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)

IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;

Primary Outcome(s)

Efficacy endpoint(DAS28);

Secondary Outcome(s)

peripheral blood lymphocyte subsets;CD4+T subgroups;

Source(s) of Monetary Support

Self support