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Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

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ClinicalTrials.gov Identifier: NCT01724268
Recruitment Status : Unknown
Verified November 2012 by Hamad Medical Corporation.
Recruitment status was:  Recruiting
First Posted : November 9, 2012
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:

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.


Methotrexate + Prednisolone vs. Methotrexate + anti TNF

Condition or disease Intervention/treatment Phase
RHEUMATOID ARTHRITIS Drug: Pred + Meth Drug: Anti TNF + Meth Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Disease activity score [ Time Frame: 4 months ]
    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 :
  1. HAQ Score [ Time Frame: 4 months ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724268

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Hamad General Hospital Recruiting
Doha, Ad Dawha, Qatar, 3050
Contact: MAGDI H ABDELRAHMAN, MBBS       mrahman1@hmc.org.qa   
Sponsors and Collaborators
Hamad Medical Corporation
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Principal Investigator: MAGDI H ABDELRAHMAN, MBBS Hamad Medical Corporation
Principal Investigator: MOHAMMED M HAMMOUDEH, MD Hamad Medical Corporation
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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01724268    
Other Study ID Numbers: 11224-12
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists