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    Summary
    EudraCT Number:2018-004241-16
    Sponsor's Protocol Code Number:B7931030
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-15
    Trial 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 ConcernedEstonia - SAM
    A.2EudraCT number2018-004241-16
    A.3Full title of the trial
    A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b, multicenter, dose-ranging study to evaluate the safety and efficacy of PF-06700841 in subjects with active psoriatic arthritis.
    A.4.1Sponsor's protocol code numberB7931030
    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 SponsorPfizer Inc.
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    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.3.1Product namePF-06700841
    D.3.2Product code PF-06700841 5mg
    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 INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    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.3.1Product namePF-06700841
    D.3.2Product code PF-06700841 25mg
    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 INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Psoriatic arthritis (PsA)
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis (PsA) is a chronic inflammatory disease
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    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 evaluate the efficacy of PF-06700841 compared to placebo in subjects with active psoriatic arthritis (PsA).
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active PsA who are TNFα inhibitor naïve.
    • To evaluate the improvement in signs and symptoms related PsA Core Domain Set in PF-06700841 treated subjects.
    • To evaluate the improvement in patient reported outcome measures related PsA Core Domain Set in PF-06700841 treated subjects.
    • To evaluate the improvement in additional composite outcome measures in PF-06700841 treated subjects.
    • To evaluate the safety and tolerability of PF-06700841.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects between 18-75 years of age, inclusive, at time of informed consent.
    • To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, a subject must have inflammatory articular disease with at least 3 points from the 5 categories, please see the categories description in protocol.
    • The subject must have evidence of active arthritis as defined by having at least 3 tender/painful joints on motion and at least 3 swollen joints at both Screening and Baseline.
    • The subject must have diagnosed active plaque psoriasis, with at least one psoriatic plaque or nail changes consistent with psoriasis, at both Screening and Baseline.
    • Ongoing treatment with a single non-biologic DMARD (limited to methotrexate, leflunomide, sulfasalazine) during the study is allowed but is not required. Other non-biologic DMARD must be discontinued.
    • Subjects who have received TNF inhibiting biologic agent must have experienced an inadequate response. Subjects could have failed no more than one TNF inhibiting biologic agent.

    See section 4.1 of the Protocol for a full list of Inclusion Criteria
    E.4Principal exclusion criteria
    • History of infection needing hospitalization or treatment detailed in protocol or history of an infected joint prosthesis. Any known current chronic infection or recurrent infection.
    • Subjects who have undergone treatment with any IL-17 inhibitor, IL-12/23 inhibitor, or IL-23 inhibitor.
    • Subjects who have undergone treatment with any Janus kinase (Jak) inhibitors, (including but not limited to tofacitinib [Xeljanz], baricitinib [Olumiant], upadacitinib, peficitinib, filgotinib).

    See section 4.2 of the Protocol for a full list of Exclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    • The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    Week 16:
    • The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of subjects who are TNFα inhibitor naïve.

    Assessed at all treatment timepoints:
    • The proportion of subjects achieving an ACR20 response at all treatment timepoints (other than Week 16), and proportion of subjects achieving an ACR50 and ACR70 response;
    • Change from baseline in the ACR response criteria components (Tender/painful joint count, Swollen joint count, Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, Health Assessment Questionnaire [HAQ] disability index [DI], and hsCRP);
    • The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response;
    • Change from baseline in the enthesitis score (using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index and Leeds Enthesitis Index);
    • Change from baseline in the Dactylitis Severity Score;
    • Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score.
    • Change from baseline in the Patient’s Global Joint and Skin Assessment Visual Analog Scale (PGJS-VAS);
    • Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);

    Assessed at all treatment timepoints except Week 2:
    • Change from baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute.
    • The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response;
    • Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA);
    • The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC);
    • Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS).

    Throughout the study:
    • Incidence of adverse events (AEs), serious adverse events (SAEs) and serious infectious events (SIEs), withdrawals due to AEs and SAEs, and laboratory abnormalities, changes in vital signs, and electrocardiogram (ECG) findings throughout the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual timepoints are included in each bullet point 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 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial6
    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 EEA55
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belarus
    Bulgaria
    Czech Republic
    Estonia
    Hungary
    Lithuania
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days6
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 196
    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)
    None
    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 Decision2019-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-17
    P. End of Trial
    P.End of Trial StatusOngoing
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