CTRI/2021/07/034531CompletedPhase 3
A Prospective, Randomized, Double Blind, Multidose, Multicenter, Parallel Group, Active Controlled Phase III Study to Compare Clinical Efficacy and Safety of Shilpa Adalimumab with Humira�® (Adalimumab) in Patients with Active Rheumatoid Arthritis. - NA
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 201
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Adult men and women patients with age ââ?°Â¥18 years and ââ?°Â¤ 65 years of age at the time of screening.
- •2.Patient should have been diagnosed with active Rheumatoid Arthritis as per 2010 American College of Rheumatology Criteria atleast 3 months prior to screening.
- •3.Patient with moderate to severe active disease defined as Disease Activity Score 28 (DAS 28) ââ?°Â¥ 3.2 despite standard anti-rheumatic DMARD treatment including atleast Methotrexate.
- •4.History of treatment with Methotrexate (MTX) 20-25 mg per week for atleast 12 weeks before screening, and being at stable dose for atleast 4 weeks before screening.
- •5.If the patients are on oral glucocorticoid ( < 10 mg/day of prednisone or equivalent) then the dose must be stable for at least 4 weeks before screening. If they are not taking glucocorticoid currently then they must have not received glucocorticoid for atleast 4 weeks prior to screening.
- •6.If patients are using NSAIDs, they should have been on a stable dose for at least 4 weeks prior to screening.
- •7.Male or female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study.
- •8.Able to self-administer injection or with help of assistant.
- •9.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
- •10.Patient should be Negative for Tuberculosis with Mantoux test and Quantiferon test for latent Tuberculosis.
Exclusion Criteria
- •1.Known hypersensitivity to Adalimumab or any of its excipients or related group of drugs.
- •2.Prior treatment with other biological response modifiers (e.g. Adalimumab, infliximab and anakinra) within 3 months from screening.
- •3.Autoimmune disease other than RA or patients with significant systemic manifestations of RA.
- •4.Pregnant or Nursing female patients.
- •5.History of diagnosis of juvenile rheumatoid arthritis (JRA) and/or RA before age 16.
- •6.History of inflammatory arthritis other than RA (e.g., systemic lupus erythematosus (SLE), or psoriatic arthritis).
- •7.Any surgical procedure for the disease, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
- •8.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeksââ?¬• prior for Leflunomide).
- •9.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeksââ?¬• prior for Leflunomide).
- •10.Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed.
- •11.Receipt of a live vaccine within 4 weeks prior to enrolment visit.
- •12.Patients with moderate to severe Heart Failure (NYHA grade III/IV).
- •13.Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation.
- •14.Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds).
Investigators
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