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    Summary
    EudraCT Number:2011-004300-38
    Sponsor's Protocol Code Number:HERO_RR10_9390
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-004300-38
    A.3Full title of the trial
    HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA, a randomised, double-blind, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does hydroxychloroquine provide effective pain relief for people with hand osteoarthritis?
    A.3.2Name or abbreviated title of the trial where available
    HERO:Hydroxychloroquine Effectiveness in Reducing Symptoms of hand OA
    A.4.1Sponsor's protocol code numberHERO_RR10_9390
    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 SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    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 supportArthritis Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameHydroxychloroquine
    D.3.2Product code n/a
    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 INNHydroxychloroquine sulphate
    D.3.9.1CAS number 747-36-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule
    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
    Pain in joints of the hand
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    The primary question to be answered by this study is whether hydroxychloroquine is an effective treatment for relieving pain in hand OA.
    E.2.2Secondary objectives of the trial
    In addition to this primary question there are several secondary questions we propose to address:

    (1) How long does it take for the treatment to work and how long will it be effective?

    (2) Does hydroxychloroquine improve health related quality of life for people with hand OA?

    (3) Does hydroxychloroquine treatment reduce joint damage as demonstrated using X-rays?

    (4) Does baseline arthritis-related inflammation predict response to hydroxychloroquine?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biological substudy, 07/02/12, v1.0
    E.3Principal inclusion criteria
    Patients to be included must meet the following criteria:
    1. • Patient-reported inadequate response/toxicity to their existing medication (to include paracetamol, oral NSAID or opioid).
    • Moderately severe symptoms (≥4/10 on a 0-10 visual analogue scale) at screening.
    • Symptoms for more than half of days in the last 3 months.
    • Fulfil the American College of Rheumatology criteria for OA (see Appendix 2).
    • Radiograph of the hands in the past 5 years with changes consistent with OA.
    • No change in the average weekly dose of analgesics (including NSAIDs) for at least 4 weeks.
    • Has used chondroitin or glucosamine for at least 4 months with no change to the average weekly dose, is not using or is willing to stop using if recently started.
    • Be able to adhere to the study visit schedule and other protocol requirements.
    • Capable of giving informed consent and the consent must be obtained prior to any screening procedures.
    E.4Principal exclusion criteria
    Patients will be excluded from this study for any of the following reasons:
    1. • Presence of inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy, Lyme disease) or fibromyalgia
    • Evidence of psoriasis
    • OA of the 1st CMC joint and no symptomatic OA in other hand joints.
    • Oral, IM, IA, or IV steroids during the last 2 months months or use of other anti-synovial agents (e.g.slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine) during the last 2 months
    .
    • Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint.
    • Planned hand surgery in the next 6 months.
    • Sensitivity, anaphylaxis or allergy to hydroxychloroquine or any other 4-aminoquinoline compound.
    • Unexplained visual impairment that is not corrected by glasses or presence of any eye problems.
    • Pregnant or lactating
    • Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
    • Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study
    • Uncontrolled disease states, such as moderate/severe asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
    • Melanoma or non-skin cancer in the past 3 years
    • IA hyaluronans to the hand joints within the last 6/12
    • Intolerance to lactose
    • Significant haematological or biochemical abnormality
    o Haemoglobin <8.5 g/dL
    o WCC <3.5 x 109/L
    o Neutrophils <1.5 x 109/L
    o Platelets <100 x 109/L
    o ALT > 2 times ULN for the laboratory conducting the test.
    o Creatinine > 1.5 times ULN for the laboratory conducting the test
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be change in average overall hand pain severity in the past 2 weeks scored on a 0-10 numerical rating score at 6 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    1. Structural assessment at baseline and 12 months
    Bilateral hand X-ray

    2. Self-reported questionnaires at baseline, 3, 6 and 12 months
    • AUSCAN (pain, stiffness and function)41 – 5 point likert scale
    • 21-point Numerical Rating Scales (NRS) and VAS scales for
    • Average overall hand pain severity / pain in the most painful joint over the past 2 weeks / 2 days *
    • NRS scales for
    • Global disease activity / average thumb pain / average pain in other joints over the past 2days
    • Severity rating of participant nominated main functional problem over the past 2 days42
    • Satisfaction with hand function over the past 2 days
    • Hand pain/aching/stiffness over the last month (no days-all days

    Self-reported questionnaires at baseline, 6 and 12 months
    • Quality of life using SF12v243 and OAQoL
    • EuroQol EQ-5D44,45
    • HADS

    Self-report measures at 3, 6 and 12 months
    • Global* improvement in hand problem
    • Global* improvement in hand pain
    • Global* improvement in ability to use hands
    *A 6-point likert scale: completely better, much better, better, no change, worse, much worse



    Other measures

    Baseline measures
    • Pain elsewhere (pain manikin)
    • Duration of hand pain over the past 12 months (<7 days, 1-4 wks, >1 month, <3 months, >3 months)
    • Onset of hand pain (last 12 months, 1-5 years, 5-10 years, 10 years or more)
    • Ultrasound synovitis score

    Clinical measures (baseline, 6 and 12 months)
    • Grip strength (JAMAR)46
    • Pinch strength (B & L pinch gauge)46
    • Functional performance using the Grip Ability Test (GAT)47
    • Joint count

    Adherence to the protocol
    Self-report measure of adherence will be included at the 6 and 12 month follow-up visits. Adherence will be monitored using the Brief Medication Questionnaire48. In addition, pharmacy will keep a record of all returned medication to provide an estimate of compliance.

    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9 and 12 months, as specified above.
    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 No
    E.6.4Safety No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    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 Yes
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state252
    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)
    Patients will return to routine care at the end of trial, which may include the use of hydroxychloroquine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation West Yorkshire CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
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