Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Methamphetamine; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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.