To compare the clinical efficacy and safety of shilpa adalimumab with Humaria in patients with active Rheumatoid arthritis.

Phase 3

Completed

• Conditions: Rheumatoid arthritis without rheumatoid factor,

• Registration Number: CTRI/2021/07/034531
• Lead Sponsor: Shilpa Biologicals Private Limited

Brief Summary

This is a prospective, randomized, double blind, multi dose, multicenter, parallel group, comparative clinical efficacy and safety study in patients with Active Rheumatoid Arthritis in between Shilpa Adalimumab (test) 40mg/0.4 ml prefilled Syringe from Shilpa Biologicals Private Limited and Humira® (Reference Adalimumab) 40mg/0.4 ml prefilled Syringe from AbbVie Deutschland GmbH & Co. KG administrated Subcutaneously till week 24 (12 doses, alternate week). Patients will be randomized in a ratio of 2:1 (120 in test arm and 60 reference arm).

History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) 2010 Criteria, for at least 3 months

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 will be invited to participate in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Study Completion: 2022-06-28
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 1.Adult men and women patients with age ≥18 years and ≤ 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) ≥ 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.

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 weeks’ 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.
• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients with an ACR20 response rate in both the treatment groups.	week 24

Secondary Outcome Measures

Name	Time	Method
1.Percentage of patients with an ACR 20 response rate in both treatment groups	2.Percentage of patients with ACR20 ACR70 response rate in both treatment groups

Trial Locations

Locations (26)

Aakash Healthcare Private Limited; 🇮🇳 Delhi, DELHI, India

Alexis Multi Speciality Hospital Private Limited; 🇮🇳 Nagpur, MAHARASHTRA, India

All India Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

AMRI Hospitals Limited; 🇮🇳 Khordha, ORISSA, India

Avron Hospitals Pvt. Ltd; 🇮🇳 Ahmadabad, GUJARAT, India

BMCRI - Bangalore Medical College and Research Institute; 🇮🇳 Bangalore, KARNATAKA, India

Care Pain and Arthritis Centre; 🇮🇳 Udaipur, RAJASTHAN, India

Dayand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Gleneagles Global Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Government Medical College and Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

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Aakash Healthcare Private Limited

🇮🇳Delhi, DELHI, India

DrGaurav Seth

Principal investigator

9151541428

gauravmarch18@gmail.com