None listed
Conditions
Interventions
FOSTAMATINIB
DOSING GROUP A: FOSTAMATINIB 100 MG TWICE DAILY (BID) FOR 24 WEEKS.
DOSING GROUP B: FOSTAMATINIB INDUCTION AND MAINTENANCE: INDUCTION OF RESPONSE WITH 100 MG BID FOR 4 WEEKS, FOLLOW
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: FOR INCLUSION IN THE STUDY SUBJECTS SHOULD FULFIL THE FOLLOWING CRITERIA: 1. PROVISION OF INFORMED CONSENT, PRIOR TO ANY STUDY-SPECIFIC PROCEDURES. NB: PATIENTS AGREEING TO PARTICIPATE IN THE OPCIONAL EXPLORATORY BIOMARKER AND/OR EXPLORATORY GENETIC RESEARCH MUST PROVIDE A SEPARATE INFORMED CONSENT. 2. MALE OR FEMALE AGED 18 AND OVER WITH A DIAGNOSIS OF RA AFTER THE AGE OF 16 ACCORDING TO THE REVISED (1987) CRITERIA OF THE AMERICAN COLLEGE OF RHEUMATOLOGY (SEE APPENDIX E FOR CRITERIA). NB: WOMEN OG CHILDBEARING POTENCIAL MAY BE INCLUDED ONLY IF USING ACCEPTABLE CONTRACEPTIVE METHODS (SEE APPENDIX H FOR DEFINITIONS). WOMEN OF CHILDBEARING POTENCIAL MUST HAVE 2 NEGATIVE PREGNANCY TESTS, AT LEAST 14 DAYS APART, PRIOR TO RANDOMISATION. 3. ACTIVE DEFINES AS: - ≥6 SWOLLEN JOINTS AND ≥6 TENDER/PAINFUL JOINTS (FROM 28 JOINT COUNT) AND EITHER - ESR ≥28 mm/h, OR - CRP ≥10 mg/L. 4. AT LEAST 1 OF THE FOLLOWING: - DOCUMENTED HISTORY OF POSITIVE RHEUMATOID FACTOR - CURRENT PRESENCE OF RHEUMATOID FACTOR - RADIOGRAPHIC EROSION WITHIN 12 MONTHS PRIOR TO ENROLMENT - PRESENCE OF SERUM ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODIES (ANTI.CCP). 5. TREATMENT WITH ORAL, SUBCUTANEOUS OR INTRAMUSCULAR METHOTREXATE FOR AT LEAST 6 MONTHS PRIOR TO RANDOMOSATION. THE DOSE AND MEANS OF ADMINISTERING METHOTREXATE MUST HAVEN BEEN STABLE BETWEEN 7.5 MG AND 25 MG PER WEEK FOR AT LEAST 6 WEEKS PRIOR TO RANDOMISATION. PATIENTS RECEIVING THE LOWER DOSES OF METHOTREXATE (7.5 MG AND 10 MG)
Exclusion criteria
Exclusion criteria: SUBJECTS SHOULD NOT ENTER THE STUDY IF ANY OF THE FOLLOWING EXCLUSION CRITERIA ARE FULFILLED: 1.FEMALES WHO ARE PREGNANT FOR LACTATING. 2.ANY SYSTEMIC INFLAMMATORY CONDITIONS (OTHER THAN RA), CONNECTIVE TISSUE DISEASE OR CHRONIC PAIN DISORDERS THAT MAY INTERFERE WITH THE INTERPRETATION OF THE OUTCOME DATA. EXAMPLES INCLUDE PSORIATIC ARTHRITIS, REACTIVE ARTHRITIS, GOUT, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), POLYMYALGIA, RHEUMATIC AND/OR TEMPORAL ARTERITIS, LYME´S DISEASE , FIBROMYALGIA AND CHRONIC FATIGUE SYNDROMES. 3.AMERICAN COLLEGE OF RHEUMATOLOGY FUNCTIONAL CLASS IV (SEE APPENDIX F) OR WHEELCHAIR/BED-BOUND. 4.UNCONTROLLED OF POORLY CONTROLLED HYPERTENSION DEFINED AS ≥140 mmHg SYSTOLIC AND/OR ≥90 mmHg DISTOLIC AT BASELINE (VISIT 2) WITH OR WITHOUT CURRENT ANTI-HYPERTENSIVE TREATMENT. NB: IF ABOVE THESE LIMITS AT VISIT 1, ANTI-HYPERTENSIVE TREATMENT MAY BE INITIATED ACCORDING TO LOCAL GUIDELINES AND PATIENTS MAY BE CONSIDERED ELEGIBLE PROVIDING BP HAS BEEN CONTROLLED BEFORE RANDOMISATION, WITH INTERVAL BETWEEN SCREENING (VISIT 1) AND BASELINE (VISIT 2) NOT EXCEEDING 4 WEEKS. IF CONTROL OF HYPERTENSION IS NOT ACHIEVED WITHIN THIS PERIOD PATIENTS SHOULD BE CONSIDERED INELIGIBLE AND NOT RE-SCREENED AGAIN. NOTE THAT THE MEAN IOF THE 2ND AND 3RD BP MEASUREMENTS SHOULD BE USED (SEE SECTION 6.4.8). 5.ABSOLUTE NEUTOPHIL COUNT (ANC)>1500/mm3 or 1.5 x 109/L. IF A PATIENT HAS ANC 1200/mm3 or 1.2 109/L, ONE RE-TEST IS ALLOWED, AT THE INVESTIGAT
Countries
Argentina, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Mexico, Portugal, South Africa, Spain, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed