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    Summary
    EudraCT Number:2006-004715-22
    Sponsor's Protocol Code Number:VX06-702-304
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-17
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2006-004715-22
    A.3Full title of the trial
    A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate
    A.4.1Sponsor's protocol code numberVX06-702-304
    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 SponsorVertex Pharmaceuticals Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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.3.2Product code VX-702
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeVX-702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    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
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    *To evaluate the effects of 2 dosing regimens of VX-702 administered with concomitant methotrexate (MTX), and MTX alone, on the concentrations of serum and urinary biomarkers of inflammation and bone resorption.
    • To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone, when administered for 12 weeks in subjects with moderate to severe rheumatoid arthritis (RA).
    E.2.2Secondary objectives of the trial
    *To evaluate the effects of VX-702 on RA disease activity based on the 20% response as defined by the American College of Rheumatology criteria (ACR20) and the Disease Activity Score 28 (DAS28) as defined by the European League Against Rheumatism (EULAR).
    • To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of VX-702 and MTX when administered concomitantly
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be male or female, 18 to 75 years of age (inclusive)
    2. Have a previously established diagnosis of RA as defined by the ACR revised criteria
    3. Have active RA ≥ 6 months in duration as defined by the ACR revised criteria for RA with total disease duration >6 months and not exceeding 10 years 4. CRP ≥1.0 mg/dL
    5. Have a swollen joint count of ≥6 out of 28 joints and tender joint count of ≥9 out of 28 joints. Joints that have had prior surgery are to be excluded from the joint count.
    6. Must have been taking MTX for at least 6 months and have been on a stable dose of MTX 12.5 to 20 mg weekly for ≥4 weeks prior to Study Day 1. The MTX dose must remain stable throughout the study; unless downward modification is required for safety reasons. Change in the route of administration is not permitted during the study.
    7. No concurrent DMARD treatment (other than a stable dose of MTX); DMARD treatment must have been discontinued ≥6 months prior to randomization
    8. Subjects receiving a nonsteroidal antiinflammatory drug (NSAID) and/or prednisone (≤10 mg/day) must have been treated at a stable dose(s) for ≥ 1 month prior to randomization. Subjects may only be taking 1 NSAID.
    9. All subjects must agree to use 2 methods of contraception, including 1 barrier method (i.e., a condom or diaphragm plus spermicide), during the treatment period and for 8 weeks after the completion of study drug (unless the subject is of documented non childbearing potential)
    10. Female subjects must have a negative pregnancy test (β-hCG) at screening before the first dose of study drug
    11. Must be an outpatient at the time of enrollment
    12. Provide informed consent to participate in the study
    E.4Principal exclusion criteria
    1. Pregnant women or nursing mothers
    2. Male subjects with female partners that are pregnant, nursing, or planning to become pregnant during the study or within 30 days of the last dose of VX-702 3.Female subjects of childbearing potential who are not using adequate contraception (defined as use of a barrier method with spermicidal jelly or intrauterine device)
    4. Have clinically significant abnormalities in prestudy clinical examination or in prestudy laboratory test results (including the presence of either hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody)
    5. Requires use of medications that may interfere with study evaluations
    6. Have any of the following concurrent medical conditions:
    • Uncontrolled diabetes or uncontrolled ischemic heart disease
    • Substantial renal impairment (creatinine clearance <40mL/min, calculated using the Cockcroft-Gault formula
    • History of cancer (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for >3 years)
    • History of liver disease
    • A prolongation of QTc interval (Fridericia correction), specifically QTc interval >450 ms in males or >480 ms in females
    • History of Torsade de Pointes or other significant arrhythmia or additional risk factors for Torsade de Pointes
    • Significant active infectious disease requiring systemic antimicrobial treatment, with the exception of uncomplicated bacterial cystitis in women
    • Evidence of tuberculosis on chest radiograph without documented adequate anti-TB treatment or known positive tuberculin skin test as follows: Subjects with ≥10 mm induration; unless completed adequate anti-TB prophylaxis documented prior to study entry and a negative chest radiograph within 6 months of study entry or unless BCG vaccination received and a negative chest radiograph within 6 months of study entry Subjects with >5mm and <10mm induration; unless a negative chest radiograph within 6 months of study entry or unless BCG vaccination received and a negative chest radiograph within 6 months of study entry
    • Any other concurrent condition which, in the opinion of the investigator, would preclude participation in or interfere with compliance with the protocol 7 Have elevation in liver function parameters at the Grade 1 toxicity level or higher (i.e., >1.5 x the upper limit of normal [ULN] for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or total bilirubin)
    8. Use of concomitant medications that are known to prolong the QTc interval
    9. Have previously taken chlorambucil or cyclophosphamide
    10. Have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1
    11. Have undergone or are undergoing treatment with another investigational drug or approved treatment for investigational use within 1 month prior to randomization 12. Have planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study
    13. Have previously participated in any study with VX-702, unless duration of administration was ≤1 week and the subject did not discontinue from the study due to an AE
    E.5 End points
    E.5.1Primary end point(s)
    •Biomarker response. Measured as the change from baseline in CRP, erythrocyte sedimentation rate (ESR), 55-kilodalton isoform soluble tumor necrosis factor receptor (sTNFRp55), and C terminal peptide Type-1 (CTX-1).
    • Safety and tolerability assessments
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Regimen Comparison
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last subject completing follow up visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    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 Decision2006-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-16
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