The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study)

Table 1 Follow up schedule and data to be collected

Study period	Induction treatment stage		Randomized stage										Early exit
Visit	S1	S2-4	V0	V1	V2	V3	V4	V5	V6	V7	V8	V9
Visit	Wk0	Wk 4\8\12	Wk0	Wk4	Wk8	Wk12	Wk20	Wk28	Wk36	Wk44	Wk52	Wk60
ICF	√
Demographic data	√
Past history and medication history collection	√
Physical examination	√	√ √	√	√	√	√	√	√	√	√	√	√	√
Urine βHCG (if applicable)	√
BCC, renal function, liver function, ESR,CRP,RF	√	√	√	√	√	√	√	√	√	√	√	√	√
Assessment committee examination	√	√ √	√	√	√	√	√	√	√	√	√	√	√
IC/EC judgement	√
Randomization		√
Hand X-ray-ran	√		√									√	√
Ultrasound of double hands	√		√									√	√
Anti-CCP antibody	√											√	√
Cost of exam and treatment	√		√	√	√	√	√	√	√	√	√	√	√
HAQ-DI/EQ-5D	√		√			√						√	√
Study Medication record	√	√	√	√	√	√	√	√	√	√	√	√	√
Concomitant medication record	√	√ √	√	√	√	√	√	√	√	√	√	√	√
AE record	√	√ √	√	√	√	√	√	√	√	√	√	√	√

ICF informed consent form, BCC blood cells count, ESR erythrocyte sedimentation rate, CRP c reactive protein, RF rheumatoid factor, IC/EC inclusion criteria/exclusion criteria, Anti-CCP antibody anti-cyclocitrulline polypeptide antibody, HAQ-DI/EQ-5D Health Assessment Questionnaire Disability Index/ Euro Qol five dimensions questionnaire, AE adverse event

ISSN: 1472-6947