Colchicine as Treatment for People With Hand Osteoarthritis

NCT04601883 | Completed Phase 4

• 1 other identifier: APPI2-2020-AD03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis Hand; Osteoarthritis Finger

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (8)

• Function

  Week 12

• Thumb base pain

  Week 12

• Pain hands

  Week 12

• Joint activity

  Week 12

• Patient global assessment

  Week 12

Study Arms (2)

Colchicine

EXPERIMENTAL

Tablet colchicine 0.5 mg administered two times daily

Drug: Colchicine 0.5 MG

Placebo

PLACEBO COMPARATOR

Tablet placebo administered two times daily

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

The intervention tablets are commercially available Colchicine "Tiofarma"

Colchicine

Placebo DRUG

Encapsulated placebo tablets. Placebo is identical to the active intervention.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Hand OA according to the ACR criteria above.
• Hand OA finger pain: Pain at rest ≥40 mm on VAS (0 to 100 mm range).

You may not qualify if:

• Comorbidities
• Other known medical disease that may affect joints, e.g. RA, gout, PsA
• Positive anti-cyclic citrullinated peptide (\>10 kU/L)
• Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
• Known blood dyscrasias and coagulation disorders
• Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
• Elevated alanine transaminase (\>45 U/L females, \>70 U/L for males)
• Creatinine clearance ≤60 ml/min
• Elevated creatine kinase (\>210 U/L females, \>280 U/L for males)
• Known allergies towards the interventions
• Drug or alcohol abuse in the last year
• Generalised pain syndromes such as fibromyalgia
• Current reflux
• Current or recurrent diarrhoeal illnesses
• Current abdominal pain

Sponsors & Collaborators

• Henning Bliddal: lead

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Copenhagen, DK, 2500, Denmark

Location

Related Publications (1)

• Dossing A, Henriksen M, Ellegaard K, Nielsen SM, Stamp LK, Muller FC, Kloppenburg M, Haugen IK, McCarthy GM, Conaghan PG, Ulff-Moller Dahl L, Terslev L, Altman RD, Becce F, Ginnerup-Nielsen E, Jensen L, Boesen M, Christensen R, Dal U, Bliddal H. Colchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial. Lancet Rheumatol. 2023 May;5(5):e254-e262. doi: 10.1016/S2665-9913(23)00065-6. Epub 2023 Apr 4.

  PMID: 38251589 DERIVED

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSci, Professor of Rheumatology

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 26, 2020
• Study Start: January 15, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

DK (1)