Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Adalimumab 40 mg/0.4 ml solution for injection SBPL-Adalimumab Injection: SBPL-Adalimumab Injection 40 mg/0.4 ml solution for injection, subcutaneous route, every other week
Control Int
Sponsors
Shilpa Biologicals Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. The participant is willing to voluntarily provide written signed and dated informed consent to participate in the study before initiating any study related procedures. 2. Adult men and women patients with age more than or equal to 18 years and less than or equal to 65 years of age at the time of screening. 3. Patient should have been diagnosed with active Rheumatoid Arthritis as per 2010 American College of Rheumatology Criteria at least 3 months prior to screening 4. Patient with moderate to severe active disease defined as Disease Activity Score 28 DAS28 more than or equal to 3.2 despite standard anti-rheumatic DMARD treatment including at least Methotrexate. 5. Patients must have had inadequate clinical response to methotrexate MTX 20 to 25 mg per week for at least 12 weeks before screening and being at stable dose for at least 4 weeks before screening. 6. Patients must be on a stable dose of folic acid more than or equal to 5 mg per week prior to baseline and must continue on a stable dose during the course of the study. 7. Patients taking oral glucocorticoid less than 10 mg per day of prednisone or equivalent then the dose must be stable for at least 4 weeks before screening 8. Patients taking regular NSAIDs Cyclooxygenase 2 COX 2 inhibitors paracetamol acetaminophen for treatment of RA symptoms are required to be on stable dose for at least 4weeks before screening 9. Patients with current diagnosis of latent tuberculosis TB or history of TB can be enrolled asper the investigators clinical judgment provided local TB treatment guidelines to be followed for tuberculosis treatment Patients will be evaluated for TB infection by the QuantiFERON TB Gold and by chest X ray at the time of screening Note Only latent TB patients will be eligible as per the investigator and pulmonologist infectious disease specialists opinion and patients with active TB will be excluded 10. Able to self-administer injection or with help of assistant.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Adalimumab or any of the components of study medication 2. Previous treatment with adalimumab other anti-TNF alpha therapies or cell depleting agents e g anti-CD20 therapy 3. Functional RA status of class IV according to the ACR 1991 revised criteria at screening 4. Uncontrolled hypertension defined as systolic blood pressure BP greater than 180 mmHg or diastolic BP greater than 100 mmHg under appropriate antihypertensive treatment 5. Systemic corticosteroids greater than 10 mg per day within 4 weeks prior to screening 6. Subjects taking high potency opioid analgesics or any intramuscular corticosteroid injection or any therapy by intra-articular injection required for treatment of acute RA flare within 4weeks before screening. 7. Patients with moderate to severe heart failure NYHA class III or IV 8. Subjects found positive for any of the serology test for Hepatitis B Virus HBV Hepatitis C Virus HCV or Human Immunodeficiency Virus HIV 9. Receipt of live vaccine within 4 weeks prior to study drug administration 10. Patients with history or pre existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Adalimumab as per investigators discretion 11. Previous participation in any clinical trial within 1 month before the entry of the study 12. Any of the following abnormal investigational values a. Hemoglobin Hb less than 10 g per dL b. Platelet count less than 100000 per mm3 c. White blood cell count less than 3000 cells per mm3 neutrophil count less than 1500 cells per mm3 d. Total bilirubin level greater than 1.5 times the upper limit of the normal laboratory range ULN e. AST and ALT greater than 3 times ULN f. Alkaline phosphatase greater than 3 times ULN g. Serum Creatinine level greater than 1.25 times ULN 13. Any other condition that in the opinion of investigator could hamper participation in the study and suspected or confirmed poor compliance as per investigators judgment in completing the trial and follow up that may make it undesirable for the subject to participate in the study 14. Pregnant women or breast feeding or planning to become pregnant while being enrolled in the study and for 3 months after the last dose of investigational product 15. Sexually active subjects and their partners who are of childbearing potential i e neither surgically sterile nor postmenopausal and not agreeing to use adequate contraception while on study and for 3 months after the last dose of study drug Male subjects must agree not to donate sperm during study and for 3 months after the last dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Adalimumab of Shilpa Biologicals Private Limited (SBPL) in post marketing phase.Timepoint: Visit 2 Baseline Visit 3 Week 12 Visit 4 Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Adalimumab of Shilpa Biologicals Private Limited (SBPL) inpost marketing phase.Timepoint: Visit 2 Baseline Visit 4 Week 24 | — |
Countries
India
Contacts
Public ContactDr Mangesh Shende
Shilpa Biologicals Private Limited
Outcome results
None listed