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    Summary
    EudraCT Number:2007-007637-39
    Sponsor's Protocol Code Number:ENRADAS-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-007637-39
    A.3Full title of the trial
    Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS)
    – a prospective randomised controlled trial - Amendment 2
    A.3.2Name or abbreviated title of the trial where available
    ENRADAS
    A.4.1Sponsor's protocol code numberENRADAS-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCharité - Campus Mitte
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    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 Voltaren resinat
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameVoltaren resinat
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess an effect of daily (continuous) versus on-demand NSAID (diclofenac) treatment on radiographic progression in AS patients at risk for radiographic progression. Radiographic change (mean) of the spine after 2 years will be assessed in the per-protocol population.
    E.2.2Secondary objectives of the trial
    Safety and the following efficacy data: the proportions of any progression (change in the mSASSS ≥ 1) and change in the mSASSS > smallest detectable difference (SDC). Per protocol analysis of radiographic change. Change in VAS back pain, BASDAI, BASFI, BASMI, CRP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Diagnosis of AS according to the 1984 modified New York criteria [17]

    · Age 18 to 65 years.

    · Active disease defined by a score ≥ 4 (VAS scale 0-10) of the BASDAI question 2 (related to back pain) at screening without NSAID therapy for at least 48 hours.

    · A clinical indication for NSAID therapy based on signs and symptoms.

    · The patient is able and willing to take oral medications.

    · The patient is capable of understanding and signing an informed consent form. The patient understands the study procedures, risks and benefits, and agrees to participate in the study giving written informed consent.

    · No current therapy with TNF agents. Any anti-TNF therapy must be stopped 4 weeks before screening.

    · In case of DMARD-therapy (methotrexate ≤25 mg/week, sulfasalazine ≤3 g/day, leflunomide, azathioprine, or hydroxychloroquine), the dose must be stable for 4 weeks prior to baseline.

    · In case of corticosteroid therapy, the dose must be stable within 2 weeks prior to baseline and must not exceed 10 mg (prednisolone equivalent) per day.
    E.4Principal exclusion criteria
    · Complete ankylosis of the cervical and lumbar spine.

    · History of any illness or has significant abnormalities on pre-study clinical or laboratory evaluation that, in the opinion of the investigator, contraindicates continuous therapy for at least 2 years with diclofenac or any other NSAID.

    · History of oesophageal, gastric, pyloric channel or duodenal ulceration documented by endoscopy or radiographic examination at any time before the screening visit, or any clinically relevant gastrointestinal bleeding.

    · Clinical gastrointestinal malabsorption

    · History of or current signs of coronary heart disease, myocardial infarction, stroke or transient ischemic attack or thrombotic events.

    · Uncontrolled hypertension;

    · Evidence of impaired renal function, defined as serum creatinine > 1.5 mg/dl

    · History of inflammatory bowel disease (Crohn’ s disease, ulcerative colitis)

    · History of or current signs of bleeding diathesis

    · History of or current signs of peripheral arterial occlusive disease

    · Abnormal liver function (AST ≥ 2x upper normal limit). Patients with known active hepatitis B or C must not participate.

    · Chronic or acute congestive heart failure (NYHA III or IV)

    · Patients with more than 2 risk factors for cardiovascular events (such as uncontrolled hypertension, hyperlipidemia, diabetes mellitus, smoking) in the past

    · Known reactions of bronchospasm, asthma, rhinitis or urticaria after intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past

    · Other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis.

    · Any active infection

    · History of HIV infection.

    · History of neoplastic disease and does not meet one of the exceptions listed below. Patients with a history of leukaemia, lymphoma, melanoma, or myeloproliferative disease are ineligible for the study regardless of the time since treatment:

    Exceptions:
    Ø adequately treated basal cell carcinoma or carcinoma in situ of the cervix
    Ø other malignancies which have been successfully treated ≥ 5 years prior to screening, where in the judgment of both the investigator and the treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening.

    · History of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

    · History of current evidence of abuse of “hard” drugs (e.g. cocaine/ heroine) or alcoholism.

    · Allergic to or has hypersensitivity to aspirin, diclofenac sodium, other NSAIDs, or coxibs.

    · Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)

    · Patient is pregnant or nursing, or planning pregnancy within the projected duration of the study: Female patients of childbearing potential must have used adequate oral or barrier contraception or abstained from sexual contact at least 30 days prior to treatment and continue contraception through the treatment period or discontinuation visit. In addition, the patient must demonstrate a negative pregnancy test before baseline. Women who are postmenopausal, or surgically sterile (status posthysterectomy or who have had bilateral tubal ligation) are exempt from this requirement. Postmenopausal is defined as no menses for the previous 6 months. (

    · Previous treatment with any investigational agent within 4 weeks prior to screening (or less than 5 terminal half-lives of elimination) of day 1 dose

    · Therapy with anti-TNF therapy within 4 weeks prior to screening

    · Combination with other NSAIDs

    · Concomitant medications with phenytoine and/ or digoxin, selective serotonin-reuptake inhibitors (SSRI), ciclosporin, probenecid, sulfinpyrazone, chinolone-antibiotics, lithium, warfarin, heparin

    · Any laboratory test result that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study.

    · Patients who participate currently in another clinical trial with investigational drug. Participation in any observational (non-therapeutic) study is possible.

    · Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).

    · Patients who are institutionalised due to regulatory or juridical order (according to AMG § 40 Abs 1, S 3, Nr 4 AMG)

    for MRI examination:
    • Patients who have claustrophobia
    • Patients with a cardiac pacemaker
    • Patients who have metal implants which are not compatible with an MRI examination
    • Patients who have any other contraindication for MRI examination
    E.5 End points
    E.5.1Primary end point(s)
    Assess an effect of daily (continuous) versus on-demand NSAID (diclofenac) treatment on radiographic progression in AS patients at risk for radiographic progression, radiographic change (mean) of the spine after 2 years in intention-to-treat popuatation as defined in the protocol.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same drug but in other dosage
    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 concerned40
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-04-15. Yes
    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 state174
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 174
    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)
    (provided in the protocol: treatment after study end is standard care)
    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 Decision2008-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-09
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