A MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFECT OF FOSTAMATINIB 100 MG TWICE DAILY ON 24-HOUR AMBULATORY BLOOD PRESSURE IN PATIENTS WITH RHEUMATOID ARTHRITIS

AstraZeneca AB,0 个研究点目标入组 0 人开始时间: 2012年9月7日最近更新: 2023年9月4日

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•1. PROVISION OF INFORMED CONSENT, PRIOR TO ANY STUDY-SPECIFIC PROCEDURES.
•NB. PATIENTS AGREEING TO PARTICIPATE IN THE OPTIONAL 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 ACR OR THE 2010 ACR-EUROPEAN LEAGUE AGAINST RHEUMATISM (EULAR) RA CLASSIFICATION CRITERIA (SEE APPENDIX F FOR CRITERIA).
•NB: WOMEN OF CHILDBEARING POTENTIAL MAY BE INCLUDED ONLY IF USING ACCEPTABLE
•CONTRACEPTIVE METHODS (SEE APPENDIX G FOR DEFMITIONS). ALL FEMALES OF CHILD-BEARING POTENTIAL MUST HAVE 2 NEGATIVE PREGNANCY TESTS, AT LEAST 14 DAYS APART, PRIOR TO RANDOMISATION.
•3. ACTIVE RA DEFINED AS:
•- ≥ 4 SWOLLEN JOINTS AND >4 TENDER/PAINFUL JOINTS (FROM 28 JOINT COUNT) AND EITHER
•- ESR ≥ 28 MM/H, OR
•- CRP ≥ 10 MG/L.
•(CONSIDERATION SHOULD BE GIVEN TO EXCLUDING PATIENTS WITH TENDER/PAINFUL ELBOW JOINTS AS THEY MAY FIND THE ABPM CUFF DIFFICULT TO TOLERATE FOR 24 HOURS).

•1. CONDITIONS THAT PRECLUDE OR RENDER DIFFICULT THE 24-HOUR ABPM TECHNIQUE IN THE JUDGEMENT OF THE INVESTIGATOR: PAINFUL SHOULDER OR ELBOW JOINTS OR OTHER REASONS THAT MAKE BP CUFF INFLATION INTOLERABLE; ARRHYTHMIAS; DERMATOLOGICAL CONDITIONS THAT WOULD PREVENT WEARING THE MONITOR; TREMOR; PROBLEMS WITH CUFF FITTING IN PATIENTS WITH CONICAL-SHAPED ARMS.
•2. BASELINE ABPM OF INSUFFICIENT QUALITY, ACCORDING TO THE CRITERIA DEFINED IN THE SITE MANUAL.
•3. FEMALES WHO ARE PREGNANT OR LACTATING
•4. 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, POLYMYALGIA RHEUMATICA AND/OR TEMPORAL ARTERITIS, LYME´S DISEASE, FYBROMYALGIA AND CHRONIC FATIGUE SYNDROMES.
•5. AMERICAN COLLEGE OF RHEUMATOLOGY FUNCTIONAL CLASS TV OR WHEELCHAIR/BED BOUND (SEE APPENDIX H).
•6. KNOWN SECONDARY CAUSES OF HYPERTENSION.
•7. EVIDENCE OF RECENT SIGNIFICANT CV DISEASE DEFINED AS ANY MAJOR CV EVENT WITHIN THE PREVIOUS 6 MONTHS INCLUDING MYOCARDIAL INFARCTION, UNSTABLE ANGINA,
•CEREBROVASCULAR ACCIDENT, PULMONARY EMBOLISM, OR HEART FAILURE NEW YORK HEART ASSOCIATION CLASS III OR IV (APPENDIX I).

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