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    Summary
    EudraCT Number:2011-000699-32
    Sponsor's Protocol Code Number:EU-0208/REMICADEPSO1006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-000699-32
    A.3Full title of the trial
    Nail involvement in psoriatic arthritis: a cross-sectional and observational prospective study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nail involvement in psoriatic arthritis: a cross-sectional and observational prospective study.
    A.3.2Name or abbreviated title of the trial where available
    NIPAL
    A.4.1Sponsor's protocol code numberEU-0208/REMICADEPSO1006
    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 SponsorUZ KULeuven, service of Rheumatology
    B.1.3.4CountryBelgium
    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 supportJanssen Biologics BV (formerly known as Centocor BV)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ KULeuven, department of Rheumatology
    B.5.2Functional name of contact pointtrial bureau Reumatologie
    B.5.3 Address:
    B.5.3.1Street Addressherestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216342541
    B.5.5Fax number3216342543
    B.5.6E-mailrik.lories@uz.kuleuven.ac.be
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologicals BV (formal Centocor BV.)
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameinfliximab
    D.3.2Product code EMEA/H/C/000240
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    psoriatic artritis
    E.1.1.1Medical condition in easily understood language
    psoriatic artritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective Part 1: to describe the prevalence and the nature of nail involvement including the vascular status in the nail bed and its relationship with DIP arthritis in a real-life cohort of patients with PsA.

    Primary objective part 2: to evaluate the efficacy of infliximab treatment on nail lesions as determined by the NAPSI score.
    E.2.2Secondary objectives of the trial
    Secondary objective part 1: to study correlations between nail lesions and nail bed vessels, hand function, and radiographic damage in a real-life cohort of patients with PsA and to assess the specificity of the nail and nail bed lesions as compared to different control groups.

    Secondary objective part 2: to evaluate the efficacy of infliximab treatment on hand function and x-ray damage
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1:
    - PsA patients must meet the CASPAR criteria
    - Psoriasis patients must meet criteria for psoriasis
    - RA patients must meet the 1987 revised ACR criteria for RA
    - Hand OA patients must meet the ACR criteria for hand OA.
    - Healthy controls

    Part 2
    - Diagnosis of psoriatic arthritis fulfilling the CASPAR criteria
    - Polyarticular disease (> 5 joints)
    - Active arthritis in at least 5 joints
    - Active disease despite adequate methotrexate treatment.
    - Health Assesment Questionnaire index of 25%.
    - Current nail disease including onycholysis, pitting, and hyperkeratosis observed on current physical examination in at least 2 finger nails.
    - Gender: males and females
    - Age: 18 to 80 years of age.
    - Patients are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules
    - Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    - Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
    - Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in Appendix 4, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated prior to the first administration of study agent
    - Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
    - The screening laboratory test results must meet the following criteria:
    o WBC (white blood cell count): 3.000 to 10.000/ml
    o ANC (absolute neutrophil count): > 500/ml
    o Hemoglobin: 12-16 mg/dl (females) – 14-18 mg/dl (males)
    o Platelets: 150-450 * 109/l
    o Serum Creatinine: 0,5 – 1,2 mg/dl
    o SGOT (AST – aspartate aminotransferase) - < 2times upper normal limit
    o SGPT (ALT – alanine aminotransferase) < 2times upper normal limit
    o Alkaline phosphatase < 2times upper normal limit
    o UA (urinalysis) with microscopic exam
    E.4Principal exclusion criteria
    Part1
    1. in the psoriasis group: patients with a history of or active joint disease
    2. In the RA en OA groep: patients with psoriasis or a history hereof and with other nail diseases
    3. In the healthy control group: presence or history of psoriasis or nail diseases.
    Part2
    1. Previous or current use of anti-TNF therapy or any other biologic.
    2. Current use of cyclosporine or leflunomide.
    3. If patients are using methotrexate, they must be on a stable dose for at least 3 months to be included in the study.
    4. If patients are using corticosteroids, they must remain on a stable dose for at least 3 months of 10 mg or less of prednisolone (or equivalent) to be included in the study.
    5. Nail or finger steroid applications including nail bed injections are forbidden during the study.
    6. Treatment with UVA/PUVA, nitroglyceride ointment as well as cyclosporin or new biologics for psoriasis are not permitted.
    7. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
    8. Have had any previous treatment with monoclonal antibodies or antibody fragments.
    9. History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion
    10. Documentation of seropositive for human immunodeficiency virus (HIV).
    11. Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
    12. Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
    13. Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
    14. Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
    15. Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules
    16. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
    17. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
    18. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Attachment D
    19. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
    20. Currently have any known malignancy other than the condition being treated or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
    21. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
    22. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.]
    23. Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
    24. Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).
    25. Have a concomitant diagnosis or history of congestive heart failure.
    E.5 End points
    E.5.1Primary end point(s)
    In part 1 of this study we test the hypothesis that nail disease is a specific feature of patients with psoriatic arthritis as compared to other chronic joint diseases. The primary endpoint here is the prevalence and nature including the vascular status in the nailbed and its relationship with DIP arthritis in a real-life cohort of PsA patients.

    In part 2 we test the hypothesis that infliximab treatment will have a beneficial effect on the severity of nail disease in a selected cohort of patients with polyarticular psoriatic arthritis and concomitant nail disease. The primary endpoint will be a change in the modified NAPSI score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    part 1 cross-sectional
    part 2 week 26 compared to baseline
    E.5.2Secondary end point(s)
    In part 1 of the study, secondary endpoint will be the relationship between modified NAPSI scores and DIP arthritis, disease activity as measured by the tender and swollen joint score, CRP, radiographic PARS score, capillaroscopy measurements, hand function (grip strength) and disease duration. The correlations between different disease activity scores and NAPSI scores will be estimated for each of the 5.
    In part 2 of the study, the key secondary endpoint will be the change in modified NAPSI scores between Week 52 and baseline. Other secondary endpoints will be changes in tender and swollen joint count, HAQ questionnaire, hand function (grip strength), changes in capillaroscopy measurements at Week 26 and at Week 52 from baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    part 1 cross-sectional
    part 2 week 26 and week52 compared to baseline
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    end of the trial: last patient last visit
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state320
    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)
    normal treatment of the condition
    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 Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-12-31
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