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

NCT03172325 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-02-02

Study results available
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Summary

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

Conditions

  • Active Rheumatoid Arthritis

Interventions

DRUG

Adalimumab

40 mg Adalimumab every other week is administered subcutaneously to all the patients.

DRUG

Methotrexate

15 mg Methotrexate is weekly administered to all the patients.

DRUG

Folic Acid

At least 1 mg Folic acid is daily administered to all the patients.

DRUG

Prednisolone

7.5 mg Prednisolone is daily administered to all the patients.

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Ahmadreza Jamshidi, Professor · Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2016-08-17
Completion
2017-01-04

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172325 on ClinicalTrials.gov