Health Condition 1: M068- Other specified rheumatoid arthritis
Conditions
Interventions
Intervention1: Tacrolimus lipid tablets of Intas Pharmaceuticals Ltd: Dose: 1 mg (three tablets)
Mode of Administration: Orally
Duration of treatment: 16 weeks
Control Intervention1: Prograf 1 mg of Astellas Pharma Canada, Inc: Dose: 1 mg (three Capsules)
Duration of treatment: 16 weeks
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to give written informed consent for participation in the study before initiating any study related procedure.. 2. Adult patients of age 18 years or older who should meet the criteria for Rheumatoid Arthritis as per American College of Rheumatology at least for last 6 months with ACR functional class Iâ??III. 3. Patients should have documented evidence of, either resistance or intolerance to 1 or more DMARDs -DMARD resistance is defined as continued active RA despite receiving a therapeutic dosage of a specific DMARD for a duration of time typically sufficient to elicit therapeutic response. Methotrexate dose should be greater than or equal to 20 mg per week for last 6 months and on stable doses for 4 weeks prior to enrolment in the study to define resistance. -DMARD intolerance is defined as the inability or unwillingness of the patient to continue therapy due to an adverse drug experience. 4. Patient with Moderate to severe diseases i.e. DAS 28 - CRP score more than 3.2 (calculated as per Appendix III) at screening. 5. Washout of any previous DMARDs given before randomization and if there is documented previous use of hydroxychloroquine then it should be at least 3 months before randomization 6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug 7. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug 8. No other serious illness including cardiac disease (ischemic heart disease, treatment-requiring arrhythmia, heart failure) that according to investigator might jeopardize the well-being, the safety of patients, the compliance to study medications and validity of data generated during the study.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Tacrolimus or any of its components 2. Patients who had received biological products (e.g. Infliximab, etanercept, etc.) or agents (e.g. leflunomide) with an inhibitory effect on the progression of joint destruction within 12 weeks before administration of the study drug. 3. Patients whose daily oral glucocorticoid dose exceeded 10 mg (Prednisolone equivalent) within 4 weeks before administration of the study drug. 4. Intra- or periarticular steroids or tacrolimus in any dosage form administered within 4 weeks prior to screening. 5. Patients who had been previously treated with Tacrolimus and found resistant for current disease. 6. Pregnant or breast-feeding female. 7. Clinically significant Liver disease (defined by levels of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, or Total bilirubin greater than or equal to 2 times the upper limit of normal). 8. Clinically significant renal disease (defined by value of either serum creatinine, serum urea or serum uric acid value above the upper limit of normal). 9. Clinically significant Bone marrow suppression defined as haemoglobin level less than 9 gm per dl, white blood cell count less than 3,000/mm3, platelet count 10. Patients with HIV or Hepatitis B or C infection. 11. Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders. 12. Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion 13. Have participated in a study of an investigational drug during the 30 days preceding randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparision of the efficacy of Tacrolimus lipid tablets versus Prograf in patients with active rheumatoid arthritis who have resistance or intolerance to DMARDs.Timepoint: Day 14, Day 28, Day 56, Day 84, Day 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation and comparision of the safety of patients exposed to the investigational medicinal products. Evaluation of the Pharmacokinetic parameters in patients with active rheumatoid arthritis who have resistance or intolerance to DMARDs.Timepoint: For Safety Day 14, Day 28, Day 56, Day 84, Day 112, Day 142 For Pharmacokinetic Day 0, Day 28, Day 56, Day 84, Day 112 | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed