In Patients with Active Rheumatoid Arthritis
- Conditions
- Health Condition 1: null- Patients with Active Rheumatoid Arthritis
- Registration Number
- CTRI/2017/10/009988
- Lead Sponsor
- Rus Biopharm LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.The Informed Consent Form has been signed and dated by the patient personally indicating that the patient was informed of all the significant aspects of the study.
2.Males or females aged 18 to 75 years inclusive at the moment of signing the Informed Consent Form.
3.The patients who are capable of complying with the regime of scheduled visits, the plan of treatment, the schedule of study-related laboratory tests and procedures.
4.The patient has agreed to use reliable methods of contraception throughout the whole study period and for 6 weeks after the end of the study.
1.Clinically relevant laboratory abnormalities at the time of the screening:
Hemoglobin <90 g/L.
Absolute neutrophil count (ANC)ï?£1.5ï?´109/L.
White blood cell count <3.0ï?´109/L.
Platelet count <100ï?´109/L.
AST/ALT level ï?³2xULN (the upper limit of normal).
AST/ALT level ï?³1.5xULN.
Serum creatinine � 132.6 µmol/L
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of the patients demonstrating response to therapy according the ACR20 criterionTimepoint: by Week 24 of the study.
- Secondary Outcome Measures
Name Time Method Proportion of the patients demonstrating response to therapy according to ACR20, ACR50, ACR70 criteriaTimepoint: by Weeks 4, 8, 12, 24 and 48;Proportion of the patients demonstrating good response, moderate response, no response to therapy according to DAS-28 criterionTimepoint: by Weeks 4, 8, 12, 24 and 48;Proportion of the patients demonstrating remission (2.6) and low-activity stage (3.2) according to DAS-28 criterionTimepoint: by Weeks 4, 8, 12, 24 and 48