The study aims to compare oral colchicine 0.5 mg administered two times daily for 12 weeks with placebo as a treatment of hand OA symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
The intervention tablets are commercially available Colchicine "Tiofarma"
Encapsulated placebo tablets. Placebo is identical to the active intervention.
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Copenhagen, DK, Denmark
Finger pain
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand from baseline to week 12, in patients with painful hand OA measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Function
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in function of both hands measured on the Australian/Canadian Hand Index Function Score spanning from 0 to 900, where higher scores equals worse function.
Time frame: Week 12
Thumb base pain
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in thumb base pain of the target hand measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Pain hands
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in pain of both hands measured on the Australian/Canadian Hand Index Pain Score spanning from 0 to 500, where higher scores equals worse pain.
Time frame: Week 12
Joint activity
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in joint activity of the target hand measured on physician tender joint count
Time frame: Week 12
Patient global assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in patient global assessment measured on a visual analogue scale spanning from 0 to 100, where 0 equals no symptoms and 100 equals worst imaginable symptoms.
Time frame: Week 12
Quality of life measured by European Quality of Life 5 Dimensions
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in quality of life measured on the European Quality of Life 5 Dimensions spanning from -0.624 to 1.000, where higher scores equals better quality of life.
Time frame: Week 12
Hand strength
To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, from baseline to week 12, in patients with painful hand OA on changes in hand strength of the target hand measured on grippit
Time frame: Week 12
Number of treatment responders according to OMERACT-OARSI response criteria
The following two conditions is observed at the post-baseline assessment: 1. In either pain (finger pain) or function (function), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a \> 50% improvement from Baseline and an absolute change from Baseline of \> 20 percent points (0-100 scale), OR 2. Improvement in at least two of the following three: * Improvement in pain (finger pain) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 points (0-100 scale) * Improvement in function (function) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 points (0-100 scale) * Improvement in patient's global assessment defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 mm (0-100 scale)
Time frame: Week 12