Design of the STRIVE-IPF trial- study of therapeutic plasma exchange, rituximab, and intravenous immunoglobulin for acute exacerbations of idiopathic pulmonary fibrosis

Table 4 Study procedures

Days on Intervention	Screening	1	2	3	5	6	9	11	13	15	19	60	90	180	270	365
Informed Consent	X
Demographics	X
Medical History	X											X	X	X	X	X
Eligibility Review	X
Symptom Assessment	X											X	X	X	X	X
Complete Physical Exam	X											X	X	X	X	X
Vital signs	X											X	X	X	X	X
Routine Blood tests	X	X
Protocol Specific Tests^a	X
Pregnancy Test (if applicable)	X
Experimental Arm Only
Experimental Blood Specimens		Before therapy										X	X	X	X	X
Routine Blood tests	X	X	X	X	X	X	X	X	X	X
O₂ requirement assessment		Before therapy									After therapy	X	X	X	X	X
TPE Collection		500 ml + 50 ml		50 ml			50 ml			50 ml
6- minute walk distance		Before therapy									After therapy	X	X	X	X	X
Treatment as Usual Arm Only
Experimental Blood Specimens		X										X	X	X	X	X
O₂ requirement assessment		X									X^b	X	X	X	X	X
6- minute walk distance		X									X^b	X	X	X	X	X
Adverse Event Monitoring	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

^aLaboratory evaluations specific for Inclusion/Exclusion Criteria to include: hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis C virus antibody (HCV Ab). tests, IgA, ANA, RF, anti-SSA, anti-CCP
^bAt discharge, discretion of the treating physician. Experimental immunologic assays (blood samples to be processed and stored frozen), for later batch shipment (while frozen) to the Coordinating Center. Telephone contacts (end of months 1, 4, 5, 7, 8, 10, 11)

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