Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

NCT01724268 | Unknown Phase 3 DMC

• 1 other identifier: 11224-12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. Hypothesis: Methotrexate + Prednisolone vs. Methotrexate + anti TNF

Conditions

RHEUMATOID ARTHRITIS

Outcome Measures

Primary Outcomes (1)

• Disease activity score

  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).

  4 months

Secondary Outcomes (1)

• HAQ Score

  4 months

Study Arms (2)

Pred + Meth

EXPERIMENTAL

Prednisolone : 10 mg daily \+ Methotrexate : 25 mg/ day ARM 1 Treatment Arm

Drug: Pred + Meth

Anti TNF + Meth

ACTIVE COMPARATOR

Etanrcept: 50 mg; Adalimumab: 40 mg; Infliximab: 3mg/kg \+ Methotrexate 25 mg per day Control Arm

Drug: Anti TNF + Meth

Interventions

Pred + Meth DRUG

PREDNISOLONE 10mg orally ONCE DAILY and Methotrexate 25 mg / day

Also known as: Prednisolone, Methotrexate

Pred + Meth

Anti TNF + Meth DRUG

Anti TNF + Meth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 years or older.
• Satisfies the 2010 American College of Rheumatology/European League Against Rheumatism Criteria for Rheumatoid Arthritis.
• Rheumatoid arthritis of \< 2 years duration
• Has active disease at the time of enrollment. (Modified Disease Activity Score ≥ 3.2)
• Demonstrates functional status of class I, II, or III as defined by American College of Rheumatology revised criteria.
• 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.
• Is able and willing to self-inject study drug if assigned to the injectable drug group or have a designee who can do so.
• 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.
• Is having normal Chest X-Ray.
• Is Hepatitis B Negative.
• Not on NSAID (e.g. Ibuprofen) or receiving the same dose of the same NSAID throughout the study period unless side effects occur
• All patients in childbearing age should use effective birth control methods
• Is capable of understanding and signing an informed consent form.

You may not qualify if:

• Received any previous treatment with Tumor Necrosis Factor inhibitor or other biologic treatments for Rheumatoid Arthritis (such as abatacept, rituximab, tocilizumab, or Anakinra).
• Received any previous treatment with oral corticosteroids (e.g. prednisolone)
• Has a known or expected allergy, contraindication, or hypersensitivity to the medications tested.
• 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.
• Received any of the following within 4 weeks before baseline visit: leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, minocycline, or D-penicillamine
• Received cyclophosphamide within 6mths before screening visit.
• Received any live (attenuated) vaccines within 4 weeks before screening visit.
• Received intra-articular or subcutaneous corticosteroid injection within 4 weeks before screening visit.
• Received bolus intramuscular/ intravenous treatment with corticosteroids (\> 20mg prednisone or equivalent) within 4 weeks before screening visit.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad General Hospital

Doha, Ad Dawha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

prednylidene; Calcium Carbonate; Prednisolone; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• MAGDI H ABDELRAHMAN, MBBS

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

• MOHAMMED M HAMMOUDEH, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

QA (1)