Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01724268
First received: November 7, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of adding one of the available anti TNF in the treatment of methotrexate inadequate responder rheumatoid arthritis patient.

Hypothesis:

Methotrexate + Prednisolone vs. Methotrexate + anti TNF


Condition Intervention Phase
RHEUMATOID ARTHRITIS
Drug: Pred + Meth
Drug: Anti TNF + Meth
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Disease activity score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    DAS 28: Disease activity score, is a modification of the original DAS score, it divides disease activity into high, moderate, low disease activity, and remission (High disease activity is DAS28 >5.1, moderate is DAS28 of >3.2 to 5.1, low disease activity is DAS28 of 2.6 to 3.2, and remission is DAS28 <2.6).


Secondary Outcome Measures:
  • HAQ Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    HAQ Score: Health Assessment Questionnaire evaluates patients' ability to perform activities of daily living through their answers to 20 questions designed to assess upper or lower extremity use. These questions are organized into eight categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each question is answered on a four-level scale of impairment ranging from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; and 3 = inability to do.


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pred + Meth

Prednisolone : 10 mg daily

+ Methotrexate : 25 mg/ day

ARM 1 Treatment Arm

Drug: Pred + Meth
PREDNISOLONE 10mg orally ONCE DAILY and Methotrexate 25 mg / day
Other Names:
  • Prednisolone
  • Methotrexate
Active Comparator: Anti TNF + Meth

Etanrcept: 50 mg; Adalimumab: 40 mg; Infliximab: 3mg/kg

+ Methotrexate 25 mg per day Control Arm

Drug: Anti TNF + Meth

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged 18 years or older.
  2. Satisfies the 2010 American College of Rheumatology/European League Against Rheumatism Criteria for Rheumatoid Arthritis.
  3. Rheumatoid arthritis of < 2 years duration
  4. Has active disease at the time of enrollment. (Modified Disease Activity Score ≥ 3.2)
  5. Demonstrates functional status of class I, II, or III as defined by American College of Rheumatology revised criteria.
  6. Is on methotrexate 25 mg weekly or the maximum tolerated dose, therapy should be for at least 3 months duration and on the highest tolerated dose for the last 4 weeks.
  7. Is able and willing to self-inject study drug if assigned to the injectable drug group or have a designee who can do so.
  8. Is PPD negative (skin test for TB exposure) or completed ≥1 month of latent TB treatment if PPD ≥ 5 or quantiferon (blood test for TB exposure) positive.
  9. Is having normal Chest X-Ray.
  10. Is Hepatitis B Negative.
  11. Not on NSAID (e.g. Ibuprofen) or receiving the same dose of the same NSAID throughout the study period unless side effects occur
  12. All patients in childbearing age should use effective birth control methods
  13. Is capable of understanding and signing an informed consent form.

Exclusion Criteria:

  1. Received any previous treatment with Tumor Necrosis Factor inhibitor or other biologic treatments for Rheumatoid Arthritis (such as abatacept, rituximab, tocilizumab, or Anakinra).
  2. Received any previous treatment with oral corticosteroids (e.g. prednisolone)
  3. Has a known or expected allergy, contraindication, or hypersensitivity to the medications tested.
  4. Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of, the study, or could preclude the evaluation of the subject's response.
  5. Received any of the following within 4 weeks before baseline visit: leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, minocycline, or D-penicillamine
  6. Received cyclophosphamide within 6mths before screening visit.
  7. Received any live (attenuated) vaccines within 4 weeks before screening visit.
  8. Received intra-articular or subcutaneous corticosteroid injection within 4 weeks before screening visit.
  9. Received bolus intramuscular/ intravenous treatment with corticosteroids (> 20mg prednisone or equivalent) within 4 weeks before screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724268

Locations
Qatar
Hamad General Hospital Recruiting
Doha, Ad Dawha, Qatar, 3050
Contact: MAGDI H ABDELRAHMAN, MBBS       mrahman1@hmc.org.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: MAGDI H ABDELRAHMAN, MBBS Hamad Medical Corporation
Principal Investigator: MOHAMMED M HAMMOUDEH, MD Hamad Medical Corporation
  More Information

No publications provided

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01724268     History of Changes
Other Study ID Numbers: 11224-12
Study First Received: November 7, 2012
Last Updated: November 8, 2012
Health Authority: Qatar: Hamad Medical Corporation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 23, 2014