Time points | Enrolment | Baseline | Day 1 | Postscheduling day 1 | |||||||||||
−t2 | −t1 | 0 | w1 | w2 | w3 | w4 | w5 | w6 | w7 | w8 | w9 | w10 | w11 | w12 | |
Enrolment | |||||||||||||||
Initial online screening | X | ||||||||||||||
Hand X-ray referral* | X | ||||||||||||||
Hand photo screening | X | ||||||||||||||
Radiographic screening | X | ||||||||||||||
Eligibility assessment | X | ||||||||||||||
Informed consent | X | ||||||||||||||
Medication washout* | X | ||||||||||||||
Treatment allocation | X | ||||||||||||||
Interventions | |||||||||||||||
Active | |||||||||||||||
Placebo | |||||||||||||||
Assessments | |||||||||||||||
Primary outcome | |||||||||||||||
VAS pain | X | X | |||||||||||||
Secondary outcomes | |||||||||||||||
AEs | X | X | X | X | X | X | X | X | X | X | X | X | |||
VAS pain | X | X | X | ||||||||||||
FIHOA | X | X | X | X | |||||||||||
PGA of disease activity | X | X | X | X | |||||||||||
AQoL-4D | X | X | X | X | |||||||||||
WPAI-GH | X | X | |||||||||||||
Other measures | |||||||||||||||
Rescue medication use | X | X | X | X | X | X | X | X | X | X | X | X | |||
Treatment adherence | X | X | X | X | X | X | X | X | X | X | X | X | |||
Capsule count | X | ||||||||||||||
Medication satisfaction | X | ||||||||||||||
Global rating of change | X | ||||||||||||||
MPsQ | X | ||||||||||||||
Computer self-efficacy | X | ||||||||||||||
Descriptive measures | |||||||||||||||
Age, gender, BMI, symptom duration, X-ray severity, HOA phenotype, comorbidity, concomitant medication | X |
*If applicable; −t3: the period between completion of online screening to signed consent form; −t2: washout period (if required); −t1: the period between baseline survey and the phone call scheduling day 1; w1–w12: week 1–12.
AEs, adverse events; AQoL-4D, assessment of quality of life four dimension; BMI, body mass index; FIHOA, Functional Index for Hand Osteoarthritis; HOA, hand osteoarthritis; MPsQ, Multidimensional Personality Questionnaire; PGA, patient global assessment; VAS, Visual Analogue Scale; WPAI-GH, Work Productivity and Activity Impairment Questionnaire General Health.