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Trial record 56 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03172325
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Cinnagen

Brief 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 diagnosis of active Rheumatoid arthritis according to EULAR criteria (European League Against Rheumatism) aged between 18 to 75 years are included. This is a Phase III, randomized, two arms, double blind (patient and assessor blinded), parallel active non inferiority controlled clinical trial. The eligible patients are randomized in a 1:1 ratio to receive CinnoRA® or Humira®. Every 2 weeks, 40 mg of either of the drugs is administered to each patient subcutaneously along with methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a six-month period.

The primary objective of this study is to assess equivalence of test- adalimumab (CinnoRA®) to the reference adalimumab (Humira®) in terms of efficacy in patients with moderate to severe active rheumatoid arthritis.

The secondary objectives of this study are:

  • To further compare efficacy of test- adalimumab to reference adalimumab
  • To assess safety of test- adalimumab compared to reference adalimumab

Condition or disease Intervention/treatment Phase
Active Rheumatoid Arthritis Drug: Adalimumab Drug: Methotrexate Drug: Folic Acid Drug: Prednisolone Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis
Actual Study Start Date : November 18, 2015
Actual Primary Completion Date : August 17, 2016
Actual Study Completion Date : January 4, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: CinnaGen adalimumab
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml in prefilled syringe Every other week 40 mg Adalimumab, was subcutaneously administered to rheumatic patients during 6 months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over a six-month period.
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.

Active Comparator: AbbVie adalimumab
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml in prefilled syringe Every other week 40 mg Adalimumab, was subcutaneously administered to rheumatic patients during 6 months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over a six-month period.
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.




Primary Outcome Measures :
  1. Percentage of Patients with DAS28-EULAR Good and Moderate Responses at week 24 [ Time Frame: Week 24 ]
    The primary variables are the percentage of patients with DAS28-EULAR Good and Moderate Responses at week 24 compared with Humira. Moderate response is defined as decrement of at least 1.2 in patient's DAS score while patient's DAS score is above 3.2 or decrement of between 0.6-1.2 while patient's DAS score is below 5.1. Good response is defined as decrement of at least 1.2 in patient's DAS score while patient's DAS score is below 3.2.


Secondary Outcome Measures :
  1. Percentage of Patients achieving ACR20, ACR50 and ACR70 Response Rates at week 24 [ Time Frame: Week 24 ]
    ACR20, ACR50 and ACR70 Response Rates are considered as respectively an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score from Baseline at Week 24.

  2. Health Assessment Questionnaire (HAQ) Disability Index at Week 24. [ Time Frame: Week 24 ]
    Quality of life is assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming, arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. There are 20 questions in the mentioned 8 sections. In each section, the highest score is considered as the main answer. Scores should be between 1 and 4 and the final answer is the average of scores relating to all sections. An increased score indicates a worsening of the disability. The disability index of Health Assessment Questionnaire (HAQ) at week 24 is reported.

  3. The incidence of Adverse Events [ Time Frame: From the time of first treatment up to the last dose of study treatment; 24 weeks. ]
    The incidence of adverse events at each visit is recorded based on patients' reports, vital signs, physical examinations, and laboratory tests for systemic safety, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female aged 18-75 years at the time of signing the informed consent form.
  • Have been diagnosed as having active RA according to The European League Against Rheumatism
  • moderately to severely active RA for at least 6 months
  • Patients who have inadequate response to the treatment with usual non-biological regimen for at least 12 weeks according to their investigator judgment.
  • Ability to comprehend and willingness to sign the Informed Consent Form for this study.

Exclusion Criteria:

  • Tuberculosis patient or latent tuberculosis patient (PPD >5mm or abnormal CXR)
  • Have been treated previously with any biological agents including any tumour necrosis factor inhibitor (including ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumabpegol), or SIMPONI® (golimumab)],Adalimumab.)
  • Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or Adalimumab
  • Women who are pregnant ,breastfeeding or planning to become pregnant during study
  • Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus (HIV)
  • Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound)
  • Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to screening
  • Have a history of chronic or recurrent infection
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times upper limit of normal.
  • Hemoglobin <8.5 g/dL.
  • Platelets <125,000/µL.
  • Leukocyte count <3500/µL.
  • Serum Creatinine>2 mg/dl
  • Concomitant use of Prednisone > 7.5 mg/day and NSAIDs
  • Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 4 weeks prior to Day 1 more than 7.5 mg/daily
  • Ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).
  • Have any of the following conditions:

    1. History of congestive heart failure.
    2. History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
    3. History of demyelinating disorders.
    4. History of multiple sclerosis
    5. History of any malignancy within the previous 5 years prior to Screening.
    6. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.

Publications:

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Responsible Party: Cinnagen
ClinicalTrials.gov Identifier: NCT03172325     History of Changes
Other Study ID Numbers: ADA.CIN.AJ94
IRCT2015030321315N1 ( Other Identifier: Food And Drug Administration of The Islamic Republic of Iran )
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Connective Tissue Diseases
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Methylprednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Antirheumatic Agents
Folic Acid
Vitamin B Complex
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors