Protocol Title : A Randomised, open labelled study in anti ... - EME

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! Glossary of Terms and Abbreviations AE Adverse Event AR Adverse Reaction ASR Annual Safety Report CA Competent Authority CI Chief Investigator CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Authorisation CTIMP Clinical Trial of Investigational Medicinal Product CTPU Cancer Prevention Trial Unit DMARD Disease Modifying Anti-Rheumatic Drug DMC Data Monitoring Committee EC European Commission EMEA European Medicines Agency EU European Union EUCTD European Clinical Trials Directive EudraCT European Union Drug Regulating Authorities Clinical Trials EudraVIGILANCE European Union Drug Regulating Authorities Pharmacovigilance GAfREC Governance Arrangements for NHS Research Ethics Committees GCP Good Clinical Practice GMP Good Manufacturing Practice IB Investigator Brochure ICF Informed Consent Form IMP Investigational Medicinal Product IMPD Investigational Medicinal Product Dossier ISRCTN International Standard Randomised Controlled Trial Number JRMO Joint Research and Management Office MA Marketing Authorisation MHRA Medicines and Healthcare products Regulatory Agency MS Member State Main REC Main Research Ethics Committee NHS R&D National Health Service Research & Development PI Principle Investigator QA Quality Assurance QC Quality Control QP Qualified Person for release of trial drug Participant An individual who takes part in a clinical trial RCT Randomised Controlled Trial REC Research Ethics Committee SAE Serious Adverse Event SAR Serious Adverse Reaction SDV Source Document Verification SmPC Summary of Product Characteristics SOP Standard Operating Procedure SSA Site Specific Assessment SUSAR Suspected Unexpected Serious Adverse Reaction TMG Trial Management Group TSC Trial Steering Committee US Ultrasound Study: R4RA EudraCT: 2012-002535-28 8 / 34
Contents ! 1. INTRODUCTION 11 1.1. Background! 11 1.2. Investigational Medicinal Products! 11 1.3. Clinical Data! 13 1.4. Rationale and Risks/Benefits! 14 2. TRIAL OBJECTIVES AND DESIGN 15 2.1. Trial Objectives! 15 2.2. Trial design! 15 2.3. Study Scheme Diagram! 16 3. STUDY POPULATION 17 3.1. Number of Subjects and Subject Selection! 17 3.2. Inclusion Criteria! 17 3.3. Exclusion Criteria! 17 3.4. Criteria for Premature Withdrawal! 18 3.5. Subject Withdrawal Criteria! 18 3.6. Subject Withdrawal Procedures! 18 4. INVESTIGATIONAL MEDICINAL PRODUCT 18 4.1. List and definition of each IMPs! 18 4.2. Formulation of IMP! 18 4.3. IMP Supply ! 18 4.4. Prescription of IMP! 18 4.5. Preparation and Administration of IMP! 18 4.6. Accountability/Receipt /Storage and Handling of IMP! 20 4.7. Dispensing of IMP! 20 4.8. IMP Stability ! 21 4.9. Prior and Concomitant Anit-Rheumatic Therapies! 21 4.10. Dose modification/reduction/ delay ! 21 5. STUDY PROCEDURES 21 5.1. Informed Consent Procedures! 21 5.2. Screening Procedures! 21 5.3. Randomization Procedures! 21 5.4. Schedule of Treatment for each visit! 22 5.5. Study visit schedule! 22 5.6. Screening! 22 5.7. Biopsy visit! 22 5.8. Baseline visit! 23 5.9. Follow up visits! 23 5.10. Imaging Evaluations! 26 Study: R4RA EudraCT: 2012-002535-28 9 / 34
Page 1 and 2: Protocol Title : A Randomised, open
Page 3 and 4: Chief Investigator Agreement Page T
Page 5 and 6: Contact details: CPTU Contact: Beno
Page 7: Statistical Methodology and Analysi
Page 11 and 12: 1 INTRODUCTION ! 1.1 Background Rhe
Page 13 and 14: 1.3 Clinical Data 1.3.1 Rituximab C
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Page 19 and 20: ! • Slowly add the total volume o
Page 21 and 22: 4.4 IMP Stability Rituximab RIituxi
Page 23 and 24: ! A baseline synovial biopsy is man
Page 25 and 26: ! Small response - CDAI50 ≥ 50% i
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Protocol Title : A Randomised, open labelled study in anti ... - EME

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