Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA

Sponsor
Cinnagen
Study ID
NCT03172325
Phase
PHASE3
Status
Completed

Conditions

  • Active Rheumatoid Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    40 mg Adalimumab every other week is administered subcutaneously to all the patients.
  • Methotrexate — DRUG
    15 mg Methotrexate is weekly administered to all the patients.
  • Folic Acid — DRUG
    At least 1 mg Folic acid is daily administered to all the patients.
  • Prednisolone — DRUG
    7.5 mg Prednisolone is daily administered to all the patients.

Study Details

The purpose of this study is to compare the efficacy and safety of adalimumab produced by CinnaGen company and AbbVie adalimumab in subjects with active Rheumatoid Arthritis. Patients with the diagnosis of active Rheumatoid arthritis according to EULAR criteria (European League Against Rheumatism) aged between 18 to 75 years will be included. This study is a Phase III, randomized, two arms, double-blind (patient and assessor blinded), parallel active-controlled non-inferiority clinical trial. The eligible patients are randomized in a 1:1 ratio to receive CinnoRA® or Humira®. Every two weeks, 40 mg of either of the drugs will be administered to each patient subcutaneously along with methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over six months. The primary objective of the study is to compare the efficacy of test- adalimumab (CinnoRA®) and the reference adalimumab (Humira®) in patients with moderately to severely active rheumatoid arthritis regarding the evaluation of EULAR criteria based on Disease activity score (DAS). The secondary objectives of this study are: * To further compare the efficacy of test- adalimumab to reference adalimumab * To assess the safety of test- adalimumab compared to reference adalimumab

Key Dates

Start date
Nov 18, 2015
Status verified
Feb 2021
Primary completion
Aug 17, 2016
Completion
Jan 4, 2017

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CinnaGen adalimumab
    CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
  • Active Comparator: AbbVie adalimumab
    Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.

Primary Outcome Measure

Percentage of Patients With DAS28-EULAR Good and Moderate Responses at Week 24 [ Time Frame: Week 24 ]

Related Studies