None listed
Conditions
Interventions
THIS TRIAL CONSISTS OF TWO PARTS:
• PART I IS DOUBLE-BLINDED WITH APPROXIMATELY 150 PATIENTS TO PROVIDE SUFFICIENT PK DATA TO ALLOW FOR AN INTERIM ANALYSIS 16 WEEKS AFTER THE LAST PATIENT IS RANDOM
Sponsors
Boehringer Ingelheim International GmbH,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. MUST GIVE WRITTEN INFORMED CONSENT AND BE WILLING TO FOLLOW THE PROTOCOL 2. MALE OR FEMALE PARTICIPANTS, BETWEEN 18 AND 80 YEARS OF AGE, WHO HAVE A DIAGNOSIS OF MODERATELY TO SEVERELY ACTIVE RA FOR AT LEAST 6 MONTHS AS DEFINED BY AT LEAST SIX SWOLLEN JOINTS (66 JOINT COUNT) AND AT LEAST EIGHT TENDER JOINTS (68 JOINT COUNT) AT SCREENING AND BASELINE (DAY 1), AND EITHER AN ERYTHROCYTE SEDIMENTATION RATE (ESR) OF >28 MM/HOUR OR A CRP LEVEL >1.0 MG/DL (NORMAL: < 0.4 MG/DL) AT SCREENING. PATIENTS MUST HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO CONVENTIONAL DMARD THERAPY INCLUDING AT LEAST ONE TNF INHIBITOR 3. POSITIVE FOR RF AND/OR ANTI-CCP ANTIBODIES. 4. CURRENT TREATMENT FOR RA ON AN OUTPATIENT BASIS: (A) MUST BE CURRENTLY RECEIVING AND TOLERATING ORAL OR PARENTERAL MTX THERAPY AT A DOSE OF 15-25 MG PER WEEK (DOSE MAY BE AS LOW AS 10 MG PER WEEK IF THE PATIENT IS UNABLE TO TOLERATE A HIGHER DOSE) FOR AT LEAST 12 WEEKS IMMEDIATELY PRIOR TO DAY 1. THE DOSE SHOULD BE STABLE FOR AT LEAST 4 WEEKS PRIOR TO DAY 1 UNTIL WEEK 24. AFTER WEEK 24 THE ADMINISTRATION ROUTE CAN BE CHANGED AT THE INVESTIGATOR´S DISCRETION. (B) PATIENTS MUST BE WILLING TO RECEIVE ORAL FOLIC ACID (AT LEAST 5 MG/WEEK OR AS PER LOCAL PRACTICE) OR EQUIVALENT DURING THE ENTIRE STUDY (MANDATORY CO-MEDICATION FOR MTX TREATMENT). (c) BIOLOGIC AGENTS AND DMARDS (OTHER THAN MTX) MUST BE WITHDRAWN AT LEAST 2 WEEKS PRIOR TO DAY 1, EXCEPT AZATHIOPRINE WHICH MUST BE WITHDRAWN AT LEAST 4 WEEKS PRIOR TO DAY 1
Exclusion criteria
Exclusion criteria: 1. ACR FUNCTIONAL CLASS IV (SEE APPENDIX 10.1) OR WHEELCHAIR/BED-BOUND. 2. PRIMARY OR SECONDARY IMMUNODEFICIENCY (HISTORY OF, OR CURRENTLY ACTIVE), INCLUDING KNOWN HISTORY OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION. 3. HISTORY OF POSITIVE PURIFIED PROTEIN DERIVATIVE TEST (POSITIVE TUBERCULOSIS [TB] TEST) WITHOUT TREATMENT FOR TB INFECTION OR CHEMOPROPHYLAXIS FOR TB EXPOSURE. 4. KNOWN CORONARY ARTERY DISEASE OR SIGNIFICANT CARDIAC ARRHYTHMIAS OR SEVERE CONGESTIVE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASSES III OR IV), OR INTERSTITIAL LUNG DISEASE OBSERVED ON CHEST X-RAY. 5. HISTORY OF IGE-MEDIATED OR NON-IGE-MEDIATED HYPERSENSITIVITY OR KNOWN ANAPHYLAXIS TO MOUSE PROTEINS OR A HISTORY OF HYPERSENSITIVITY TO ANTIBODY THERAPY. 6. HISTORY OF CANCER INCLUDING SOLID TUMORS, HEMATOLOGIC MALIGNANCIES, AND CARCINOMA SITU (EXCEPT PARTICIPANTS WITH PREVIOUS RESECTED AND CURED BASAL OR SQUAMOUS CELL CARCINOMA, TREATED CERVICAL DYSPLASIA, OR TREATED IN SITU GRADE I CERVICAL CANCER WITHIN 5 YEARS PRIOR TO THE SCREENING VISIT). 7. HISTORY OF INFLAMED PANCREAS OR CURRENT PEPTIC ULCER DISEASE. 8. RECEIPT OF A LIVE/ATTENUATED VACCINE WITHIN 12 WEEKS PRIOR TO THE SCREENING VISIT.
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Estonia, France, Germany, Greece, Guatemala, Hungary, Ireland, Italy, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed