[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Condition

Rheumatoid Arthritis

Treatment type

Interventional

Investigational product

DRL_RI

Phase

Phase 1/Phase 2

Sponsor

Dr. Reddy's Laboratories Limited

ClinicalTrials.gov identifier

NCT02296775

Study number

RI-01-003

Date first posted

November 18, 2014

Date last update

November 18, 2014

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About the study

This study will compare the plasma pharmacokinetic profile and the change in disease activity score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be monitored for safety, B cell depletion and recovery, and for the development of immune responses to the administered study drugs

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. s) for at least 6 months and on stable dose for at least 3 months 6. Patients must be on a stable dose of folic acid or equivalent (≥5 mg per
  2. week) 7. Chest X-ray not suggestive of any lung infections including pulmonary tuberculosis (
  3. TB) 8. Contraception required per protocol
Exclusion criteria
  1. TNF) alfa antagonists or other biologic DMARDs Other prior or concurrent therapies may also be excluded 2. Any clinically relevant abnormality detected on screening history, physical examination, clinical laboratory, chest X-ray, or electrocardiogram (ECG), other than values consistent with RA 3. Evidence of active, suspected or inadequately treated TB 4. Positive serological test for hepatitis C virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus 5. History of cardiovascular disease, history of stroke, or uncontrolled hypertension 6. History of lymphoproliferative disease or organ allograft 7. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for >5
  2. years) 8. History of allergy (medication
  3. history) to any of the compounds used in the study 9. Pregnant or lactating women or women planning to become pregnant during the study

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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