Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01724268
• Date of registration: 07/11/2012
• Prospective Registration: No
• Primary sponsor: Hamad Medical Corporation
• Public title: Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient
• Scientific title: Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study
• Date of first enrolment: May 2012
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01724268
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Qatar

Contacts

• Name: MAGDI H ABDELRAHMAN, MBBS
• Affiliation: Hamad Medical Corporation

• Name: MOHAMMED M HAMMOUDEH, MD
• Affiliation: Hamad Medical Corporation

• Name: MAGDI H ABDELRAHMAN, MBBS

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

RHEUMATOID ARTHRITIS

Intervention(s)

Drug: Pred + Meth

Drug: Anti TNF + Meth

Primary Outcome(s)

Disease activity score [Time Frame: 4 months]

Secondary Outcome(s)

HAQ Score [Time Frame: 4 months]

Secondary ID(s)

11224-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors