CTRI/2010/091/000070
Completed
未知
An Open label, balanced, randomized, multiple-dose two-period, two-treatment, two-sequence, steady state, crossover comparative bioequivalence study of two formulations of Azathioprine in adult patients with Rheumatoid Arthritis (RA)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Sponsor
- Orion Pharma
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\.Adult patients, either sex, aged between 18 and 55 years (both inclusive) with acceptable BMI.
- •2\.RA patients on maintenance therapy with twice daily 50 mg oral Azathioprine with or without a fixed dose (maximum of 30 mg/week) of Methotrexate.
- •Having moderate to aggressive disease stage, as per American Rheumatism Association defined by the presence of at least 3 of the following criteria:
- •(a) tenderness of more than 6 joints
- •(b) swelling of more than 3 joints
- •(c) morning stiffness longer than 45 minutes
- •(d) articular index greater than 20
- •(e) ESR greater than 28 mm/h.
- •3\.CRP, ANTI\-CCP antibodies \& RA factor done within 6 months of screening or at screening suggestive of active Rheumatoid arthritis.
Exclusion Criteria
- •1\.Adult patients with RA on therapy with any other agent apart from twice daily dose of Azathioprine alone or along with use of NSAIDs, fixed low\-dose glucocorticoids and/or fixed dose of Methotrexate.
- •2\.Anemia (hemoglobin \< 08 gm %).
- •3\.Patients with low or absent TPMT activity who are at increased risk.(\<5\.5 unit).
- •4\.Bone marrow suppression (platelets / leucocytes \< 1 x lower normal level).
- •5\.Small bowel surgery interfering significantly with resorptive area.
- •6\.Concomitant use of allopurinol, ACE\-inhibitors or furosemide.
- •7\.Pregnancy, expected pregnancy or lactation within 6 months.
- •8\.Subjects who have a history of a known allergy/sensitivity to study drug or its excipients.
- •9\.Subjects who have had serious infections (eg, active hepatitis, pneumonia, or pyelonephritis) within 2 months of screening. Less serious infections (such as acute upper respiratory tract infection \[colds] or a simple urinary tract infection) need not be considered as exclusion at the discretion of the investigator.
- •10\.Subjects who have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to Screening.
Outcomes
Primary Outcomes
Not specified
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