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    Summary
    EudraCT Number:2020-002803-20
    Sponsor's Protocol Code Number:APPI2-2020-AD03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-002803-20
    A.3Full title of the trial
    Colchicine treatment for patients with hand osteoarthritis: A randomised, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Colchicine as treatment for persons with hand osteoarthritis
    A.3.2Name or abbreviated title of the trial where available
    COLOR
    A.4.1Sponsor's protocol code numberAPPI2-2020-AD03
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorParker Instituttet
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOAK Foundation
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportIMK Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportA. P. Moeller Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAase and Ejnar Danielsens Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Medical Association
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParker Instituttet
    B.5.2Functional name of contact pointOsteoarthritis Outpatient Clinic
    B.5.3 Address:
    B.5.3.1Street AddressNordre Fasanvej 57
    B.5.3.2Town/ cityFrederiksberg
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538164158
    B.5.6E-mailbfh-fp-parkerinst@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Colchicin
    D.2.1.1.2Name of the Marketing Authorisation holderTiofarma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColchicine
    D.3.9.3Other descriptive nameCOLCHICINE PH. EUR.
    D.3.9.4EV Substance CodeSUB178502
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.0005
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hand osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Hand osteoarthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10019115
    E.1.2Term Hand osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of oral colchicine 0.5 mg bid, relative to placebo, on changes in finger joint pain of the target hand measured on a visual analogue scale (VAS) from baseline to week 12, in patients with painful hand OA.
    E.2.2Secondary objectives of the trial
    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:
    o Function of both hands measured on the AUSCAN Hand Index Score
    o Thumb base pain of the target hand measured on a VAS scale
    o Pain of both hands measured on the Australian/Canadian (AUSCAN) Hand Index Score
    o Joint activity of the target hand measured on physician tender joint count
    o Patient global assessment measured on a VAS scale
    o Quality of life measured on the European Quality of Life 5 Dimensions (EQ-5D)
    o Hand strength of the target hand measured on grippit
    o Treatment response measured on the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria [27] at week 12, in patients with painful hand OA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual will be eligible for study participation if he/she meets the following criteria:
    1. Age ≥18 years.
    2. Hand OA according to the ACR criteria above.
    3. Hand OA finger pain: Pain at rest ≥40 mm on VAS (0 to 100 mm range).
    E.4Principal exclusion criteria
    A participant will be excluded from the study if he/she meets any of the following criteria listed below. Some exclusion criteria require a blood sample, please see section “Visit 2: Screening visit”. Known diseases will be based on diagnosis registered in the participants health journal. If an exclusion diagnose is suspected necessary diagnostics will be performed before inclusion in the study.
    Comorbidities
    1. Other known medical disease that may affect joints, e.g. RA, gout, PsA
    2. Positive anti-cyclic citrullinated peptide (>10 kU/L)
    3. Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
    4. Known blood dyscrasias and coagulation disorders
    5. Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
    6. Elevated alanine transaminase (>45 U/L females, >70 U/L for males)
    7. Creatinine clearance ≤60 ml/min
    8. Elevated creatine kinase (>210 U/L females, >280 U/L for males)
    9. Known allergies towards the interventions
    10. Drug or alcohol abuse in the last year
    11. Generalised pain syndromes such as fibromyalgia
    12. Current reflux
    13. Current or recurrent diarrhoeal illnesses
    14. Current abdominal pain
    15. Known peripheral neuropathies
    16. Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
    Medical history
    17. History of hand surgery within 12 months prior enrolment.
    18. History of arthroplasty or arthrodesis in the hand
    Management strategies
    19. Treatment with P-glycoprotein inhibitors and/or cytochrome P450 3A4 (CYP3A4) inhibitors, see section “Colchicine safety in drug-drug interactions” and table 7. If potential participants have been treated with these pharmaceuticals previously, treatment must be terminated 5 half-lifes before initiation of study drug.
    20. Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months.
    21. Participation in experimental device or experimental drug study 3 months prior to enrolment.
    22. Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
    23. Intra-articular corticosteroids into any joint 1 months before inclusion
    24. Current use of synthetic or non-synthetic opioids
    25. Scheduled surgery during study participation
    26. Planning to start other treatment for hand OA in the study participation period.
    Reproductive system
    27. Planned pregnancy within the study period, pregnancy or insufficient anti-conception therapy for female fertile participants. Sufficient anti-conception therapy consists of intra-uterine device (coil) or hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections).
    28. Breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in VAS finger joint pain of the target hand at week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks of treatment and 12 weeks of treatment
    E.5.2Secondary end point(s)
    Secondary outcomes are change from baseline to week 12 in:
    • Physical function of both hands assessed by AUSCAN physical function subscale
    • VAS thumb base pain of the target hand
    • Pain of both hands assessed by AUSCAN hand pain subscale
    • Joint activity of the target hand assessed by physician tender joint count in the target hand
    • VAS patient global assessment
    • Quality of life assessed by the EQ-5D
    • Hand strength of the target hand assessed by grippit
    • Fulfilment of OMERACT-OARSI responder criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Joint activity and hand strength are only assessed at week 12
    All other secondary end points are assessed at week 4 and week 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    A post-study telephone visit at week 16 will assess study drug withdrawal symptoms (i.e. symptoms that occur upon abrupt discontinuation of study drug) and general hand OA symptoms. Post-study treatment will consist of conventional hand OA treatment. The post-study visit will also be used as follow-up for any unresolved adverse events and serious adverse events.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-03
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