CHECK LIST FORM-SCREENING

Transcription

1 CHECK LIST FORM-SCREENING Participant Initials: Date of Birth: Evaluation Date: Were the following forms completed for this visit? Eligibility Form Done t Done Baseline medical History Form Done t Done Enrolment Form Done t Done Consent Form Done t Done Clinical Labs Done t Done Con meds Form Done t Done If any of the forms or research specimens are not done, please explain why below Date: Signature Page 1 of 1 Version 20 June 2013

2 ELIGIBILITY REVIEW FORM Participant Initials: Date of Birth: Evaluation Date: Inclusion Criteria To be included in the trial, the following must all be answered YES 1 Provided written informed consent Date of Consent 2 A diagnosis of ANCA-associated vasculitis (AAV) [granulomatosis with polyangiitis or microscopic polyangiitis], according to the definitions of the Chapel Hill Consensus Conference 3 Current or historical ANCA positivity either by ELISA or immunofluorescence 4 Disease relapse defined by one major or three minor disease activity items on the Birmingham Vasculitis Activity Score for Wegener s (BVASWG), in patients that have previously achieved remission following at least 3 months of induction therapy, with a combination of glucocorticoids and an immunosuppressive agent (cyclophosphamide or methotrexate or rituximab) Page 1 of 4 Version 20 June 2013

3 ELIGIBILITY REVIEW FORM Participant Initials: Date of Birth: Exclusion Criteria To be included in the trial, the following must all be answered NO 1 Age < 15 years (age < 18 years at centres that do not treat paediatric patients) 2 Exclusions related to medication: Previous therapy with: a Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months b Alemtuzumab or anti-thymocyte globulin (ATG) within the last 12 months c IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months d Any investigational agent within 28 days of screening, or 5 half lives of the investigational drug (whichever is longer) 3 Exclusions related to general health: a Significant or uncontrolled medical disease not related to AAV, which in the investigators opinion would preclude patient participation b Presence of another multisystem autoimmune disease, including EGPA (Churg-Strauss), systemic lupus erythematosus, anti-gbm disease, or cryoglobulinaemic vasculitis Page 2 of 4 Version 20 June 2013

4 ELIGIBILITY REVIEW FORM Participant Initials: Date of Birth: Exclusion Criteria To be included in the trial, the following must all be answered NO c Any concomitant condition anticipated to likely require greater than 4 weeks per year of oral or systemic glucocorticoid use and which would preclude compliance with the glucocorticoid protocol (eg poorly-controlled asthma, COPD, psoriasis, or inflammatory bowel disease) d History of severe allergic or anaphylactic reactions to humanised or murine chimeric monoclonal antibodies e Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection f Ongoing or recent (last 12 months) evidence of active tuberculosis or known active infection (screening for tuberculosis is part of standard of care in patients with established AAV) or evidence of untreated latent tuberculosis Screening for tuberculosis is as per local practice g History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure h Pregnancy or inadequate contraception in women of childbearing potential i Breast feeding or lactating Page 3 of 4 Version 20 June 2013

5 ELIGIBILITY REVIEW FORM Participant Initials: Date of Birth: Exclusion Criteria To be included in the trial, the following must all be answered NO j Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 4 Exclusions related to laboratory parameters: a Bone marrow suppression as evidenced by a total white count < 4 x10 9 l, haemoglobin < 7 gmdl or platelet count < 100,000μl b Aspartate aminotransferase or alanine aminotransferase or amylase > 25 times the upper limit of normal, unless attributed to vasculitis Date: Signature: Page 4 of 4 Version 20 June 2013

6 ENROLMENT FORM Participant Initials: Date of Birth: Enrolment This information is needed to use the web-interface: Name of the PI performing enrolment Weight kg OR lb Height cm ft in OR Selected predniso(lo)ne induction regimen 1A Starting dose 10 mgkgday 1B Starting dose 05 mgkgday ANCA Type anti-pr3 anti-mpo Relapse Type MAJOR RELAPSE (SEVERE) New or recurrent disease activity that occurs after remission has been initially induced and includes at least one major item of the BVASWG MINOR RELAPSE (NON SEVERE) New or recurrent disease activity that occurs after remission has been initially induced but does not constitute a major relapse and does not affect a major item of the BVASWG This information is to be taken from the website Body Surface Area m² Enrolment Date Target Randomisation Date (4 months after enrolment) Induction Dose of Rituximab (mginfusion) Study ID - mg Date: Signature: Page 1 of 1 Version 20 June 2013

7 BASELINE MEDICAL HISTORY FORM Participant Initials: Date of Birth: Evaluation Date: Demography Gender: Female Male Race: White Black Asian Hispanic Other If other, please specify Date of first diagnosis: Vasculitis related signs and symptoms since diagnosis Biopsy performed at any time for the diagnosis of GPAMPA? If YES, please tick the appropriate organ: If other, please specify Kidney Lung Skin Sinuses Nerve Other Has the subject ever had a positive immunofluorescence assay for ANCA? If YES, please tick the appropriate pattern: C-ANCA P-ANCA Has the subject ever had a positive ELISA assay for anti PR3 ANCA? Has the subject ever had a positive ELISA assay for anti MPO ANCA? Page 1 of 5 Version 20 June 2013

8 BASELINE MEDICAL HISTORY FORM System 1 Constitutional Symptoms 2 Joints 3 Skin Manifestation Checklist: (Organ manifestations since diagnosis) Body System Abnormality ne 4 Mucous membraneseyes 5 EarseThroat 6 Heart 7 Gastrointestinal Tract Participant Initials: Date of Birth: Evaluation Date: Weight loss Fevers Arthralgia(s) Arthritis Purpura Ulcer(s) Gangrene Raynaud s phenomenon Livedo reticularis Splinter hemorrhages Subcutaneous nodules Oral ulcer(s) Gingivitis Conjunctivitisepiscleritis Retro-orbital massproptosis Uveitis Scleritis Retinal exudateshemorrhage Bloody nasal discharge Nasal crustingulcer Nasal septal perforation Nasal collapse Sinus involvement Swollen salivary gland Subglottic inflammation Hearing loss - conductive Hearing loss - sensorineural Auricular chondritis Pericarditis Valvular involvement Mesenteric ischemia Page 2 of 5 Version 20 June 2013

9 BASELINE MEDICAL HISTORY FORM Participant Initials: Date of Birth: Evaluation Date: System 8 Lungs 9 Kidneys 10 Nervous System Manifestation Checklistcontinued Body System Abnormality ne 11 Other, Please specify below Pleurisy dules or cavities Endobronchial involvement Alveolar haemorrhage Other pulmonary infiltrate oattributed to AAV Respiratory failure (intubation) Proteinuria Haematuria RBC casts Elevated serum creatinine Kidney transplantation Meningitis Spinal cord involvement Stroke Cranial nerve involvement Sensory peripheral neuropathy Motor mononeuritis multiplex Encephalitis Mass lesion Page 3 of 5 Version 20 June 2013

10 BASELINE MEDICAL HISTORY FORM Participant Initials: Date of Birth: Evaluation Date: Comorbidity form Please check all conditions the subject has a known history or current diagnoses of Diagnosis Is the condition diagnosed? Hypertension Ischemic Heart Disease Chronic Lung Disease (eg COPD, Asthma) Unknown Unknown Unknown Cerebro-Vascular Disease Unknown Cancer (including non-melanoma skin cancer) Please specify Unknown Venous Thromboembolism Diabetes Unknown Unknown Page 4 of 5 Version 20 June 2013

11 BASELINE MEDICAL HISTORY FORM Participant Initials: Date of Birth: Evaluation Date: Medication history Has the subject ever received any of the following as treatment for their vasculitis? Methylprednisolone Predniso(lo)ne Oral Cyclophosphamide If yes, cumulative dose: g IV Cyclophosphamide If yes, cumulative dose: g Rituximab If yes, cumulative dose: mg Azathioprine Methotrexate Mycophenolate Mofetil SulfamethoxazoleTrimethoprim (as treatment for Vasculitis rather than PJP (PCP) prophylaxis) Plasma Exchange IVIG Anti-TNFs Other Immunosuppression Drug name: Drug name: Drug name: Date: Signature: Page 5 of 5 Version 20 June 2013

12 CLINICAL LABORATORY TESTS FORM Participant Initials: Date of Birth: Evaluation Date: Please select Assessment Point Screening Baseline Month 15 Month 3 Month 4 Month 8 (Month 0) Month 12 Month 16 Month 20 Month 24 Month 27 Month 30 Month 36 Month 42 Month 48 Clinical Labs Laboratory Data Haemoglobin Date Test Done gdl t measured gl mmoll Platelets x 10 9 L t measured WBC x 10 3 mm 3 t measured x 10 9 L ESR mmh t measured Date Test Done Creatinine µmoll t measured gdl CRP mgl t measured mgdl Date Test Done ALT or UL t measured AST UL t measured Page 1 of 2 Version 20 June 2013

13 CLINICAL LABORATORY TESTS FORM Participant Initials: Date of Birth: Assessment Point: Laboratory Data ANCA Date Test Done Anti-PR3 Positive t measured Negative Anti-MPO Positive t measured Negative Lymphocyte markers Date Test Done CD19 x 10 3 mm 3 t measured x 10 9 L CD19 Percentage % Immunoglobulins Date Test Done IgG gl t measured mgdl IgM gl t measured mgdl IgA gl t measured mgdl Date: Signature: Page 2 of 2 Version 20 June 2013

14 CONCOMITANT MEDICATIONS FORM Participant Initials: Date of Birth: Evaluation Date: Please select Assessment Point Screening or Baseline (Month 0) Month 15 Month 3 Month 4 Month 8 Month 12 Month 16 Month 20 Month 24 Month 27 Month 30 Month 36 Month 42 Month 48 Concomitant medications (add more pages if applicable) Page of All drugs that are on previous Concomitant Medication Lists MUST be on this list if they are ongoing Please record only prescribed medications It is not necessary to list vitamins and other dietary supplements Medication Name Dose Units (eg mg) Frequency* Comments * Frequency 1=Once daily 2=Twice daily 3=Three times a day 4=Four times a day 5=Alternate days 6=Weekly 7=Other (Please specify) 0=As required Date: Signature: Version 20 June 2013