Display again
NCT03783026 | SNCTP000003323

Eine Studie zur Bewertung der Auswirkungen eines PsA-Medikaments namens Apremilast auf die Ergebnisse von bildgebenden Verfahren, beurteilt anhand von Magnetresonanztomographie (MRT) bei Patienten mit Psoriasis-Arthritis (PsA, eine entzündliche Arthritis).

Data source: BASEC (Imported from 19.11.2019), WHO (Imported from 17.11.2019)
Changed: 08.11.2019
Disease category: Haut- und Bindegewebekrankheiten (nicht Krebs)

Brief description of trial (Source of data: BASEC)

Mit dieser Studie wird die Wirkung eines Medikaments namens Apremilast (kommerziell erhältlich als Otezla) auf die Ergebnisse bildgebender Verfahren, beurteilt anhand von Magnetresonanztomographie (MRT), auf klinische Daten und auf von Patienten berichtete Ergebnisse untersucht.
Die Behandlung enthält den als Apremilast bezeichneten Wirkstoff, der bei der Behandlung von PsA nachweislich wirksam ist, indem er spezifische Reaktionen in Ihrem Körper, die durch abnorme Entzündungswerte hervorgerufen werden, verhindert. Die Behandlung wird zweimal täglich als Tablette eingenommen (30 mg zweimal täglich). Apremilast ist eine in der Schweiz und in Europa bereits für die Anwendung bei Patienten mit PsA zugelassene Behandlung und es ist nicht das Ziel dieser Studie, ein neues experimentelles oder nicht zugelassenes Medikament zu testen.

Health conditions investigated (Source of data: BASEC)

Die Teilnahme steht allen Personen offen, die an einer aktiven PsA mit bis zu 5 Jahren Krankheitsdauer leiden, die zuvor nicht mit TNF-Blockern oder anderen biologischen krankheitsmodifizierenden Antirheumatika (disease-modifying antirheumatic drugs, [DMARDs]) behandelt wurden.

Health conditions (Source of data: WHO)

Psoriatic Arthritis

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Sie werden für bis zu 8 Studientermine ins Prüfzentrum kommen (1 Voruntersuchungstermin + 6 Besuchstermine während des Behandlungsabschnitts + 1 möglicher Nachbeobachtungsbesuch) und Ihre Studienteilnahme wird bis zu 56 Wochen dauern.
Die Besuchstermine sollten 30 Minuten bis etwa 2,5 Stunden (Besuchstermine mit MRT-Scans) dauern, auch abhängig davon, welche Tests/Fragebögen bei den einzelnen Besuchsterminen erforderlich sind.
Eine Übersicht über die Studienmassnahmen, die nicht alle bei jedem Besuchstermin vorgesehen sind:
- Körperliche Untersuchung
- Körpergewicht
- Vitalzeichen (Blutdruck, Körpertemperatur, Herzfrequenz)
- Körpergrösse
- Schwangerschaftstest (nur für Frauen, die schwanger werden können)
- Blutentnahme
- Urinabgabe
- Blutentnahme für HLA-B27-Analyse (optional)
- Erfassung unerwünschte Ereignisse, Begleitmedikamente und -massnahmen
- MRT-Scans
- Klinische Beurteilung der Krankheitsaktivität und des Ansprechens auf die Behandlung
- Erfassung von Patienten berichtete Ergebnisse

Interventions (Source of data: WHO)

Drug: CC-10004

Criteria for participation in trial (Source of data: BASEC)

- Männer oder Frauen, im Alter von 18 Jahren und ä zum Zeitpunkt der Zustimmung

- Sie haben eine dokumentierte Diagnose von PsA von ≥ 3 Monate UND ≤ 5 Jahre in der Dauer, die die CASPAR-Kriterien für PsA (Anhang B, Taylor, 2006) zum Zeitpunkt des Voruntersuchungbesuchs erfüllt. [CASPAR = Classification Criteria for Psoriatic Arthritis]

- Sie dürfen nicht zuvor mit einem TNF-Blocker oder einem anderen biologischen Medikament zur PsA-Behandlung behandelt worden sein.

Exclusion criteria (Source of data: BASEC)

- Kontraindikation zur MRT-Untersuchung, einschließlich, aber nicht beschränkt auf: intrakranielle Metall-Clips; Herzschrittmacher; Insulinpumpen; implantierte Hörgeräte; Neurostimulatoren; Metall-Hüftprothesen; schwere Klaustrophobie oder Unfähigkeit im MRT-Gerät in einer geeigneten Position zu liegen, um qualitativ hochwertige Bilder zu erhalten; Überempfindlichkeit gegenüber Gadolinium-Kontrastmittel in der Vergangenheit;

- Schwere Niereninsuffizienz (Kreatinin-Clearance von weniger als 30 mL pro Minute, geschätzt von die Cockroft-Gault Gleichung), die die Verwendung der Gadoliniumverstärkung verhindern würde.

- klinisch bedeutsame kardialen, endokrinen, endokrinen, Lungen-, neurologische, psychiatrische, hepatische, renale, hämatologische, immunologische Erkrankungen oder andere schwere unkontrollierte Krankheiten in der Vergangenheit (wie vom Prüfarzt festgestellt)

Inclusion/Exclusion Criteria (Source of data: WHO)


Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Males or females, aged = 18 years at time of consent

2. For all regions, the local Regulatory Label for treatment with apremilast must be
followed.

3. Must understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures being conducted

4. Able to adhere to the study visit schedule and other protocol requirements

5. Have a documented diagnosis of PsA of = 3 months AND = 5 years in duration, meeting
the CASPAR criteria for PsA at the time of Screening Visit

6. Have = 3 swollen AND = 3 tender joints, with hand involvement (defined as = 1 swollen
joint or dactylitis [each clinically active joint of a dactylitic digit is counted as
one joint]).

7. Have at least 1 active enthesitis site (one of the SPARCC or LEI sites)

8. Must not have been treated previously with a TNF blocker or other biologic drug for
PsA treatment

9. Must not have been treated with more than 2 csDMARDs

10. Subjects taking csDMARDs, with the exception of MTX, cyclosporine, or LEF, do not
require a washout period. However, they must discontinue the csDMARD treatment at
least one day prior to their Baseline Visit (ie, Visit 2, Day 1)

11. Subjects who have been previously treated with MTX for < 6 months and who are not on
stable doses for at least 3 months will require a 28-day washout prior to the Baseline
Visit (ie, Visit 2, Day 1) to participate in the study

12. Subjects who have been previously treated with LEF will require a 12-week washout
prior to the Baseline Visit (ie, Visit 2, Day 1), or treatment with cholestyramine,
per LEF prescribing label (ie, 8 g cholestyramine 3 times daily for 11 days)

13. Subjects who have been previously treated with cyclosporine will require a 28-day
washout prior to the Baseline Visit (ie, Visit 2, Day 1) to participate in the study

14. If taking MTX (= 25 mg/week), continuity of treatment will be allowed if duration of
treatment is = 6 months and on a stable dose for at least 3 months prior to the
Baseline Visit (ie, Visit 2, Day 1)

15. If taking oral glucocorticoids, must be on a stable dose of prednisone = 10 mg/day or
equivalent for at least 4 weeks prior to the Baseline Visit (ie, Visit 2, Day 1)

16. If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 4 weeks
prior to Baseline Visit (ie, Visit 2, Day 1)

17. A female of childbearing potential (FCBP)† must have a negative pregnancy test at
screening and baseline. While on IP and for at least 28 days after taking the last
dose of IP, a FCBP who engages in activity in which conception is possible must use
one of the approved contraceptive§ options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception
(oral, injection, implant, transdermal patch, vaginal ring); intrauterine device;
tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex
condom or non-latex condom NOT made out of natural [animal] membrane [for example,
polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b)
cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

† An FCBP is defined as a sexually mature female who 1) has not undergone a
hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the
surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24
consecutive months (that is, has had menses at any time during the preceding 24
consecutive months).

§ The female subject's chosen form of contraception must be effective by the time the
female subject is screened into the study (for example, hormonal contraception should
be initiated at least 28 days before screening).

18. Must be in general good health (except for PsA) as judged by the investigator, based
on medical history, physical examination, and clinical laboratories. (Note: The
definition of good health means a subject does not have uncontrolled significant
comorbid conditions).

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Contraindication to MRI examination including, but not limited to, intracranial metal
clips, heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators,
metal hip replacements, profound claustrophobia or inability to lie in the MRI machine
in an appropriate position to obtain quality images, history of hypersensitivity to
gadolinium contrast agent

2. Severe renal impairment (creatinine clearance of less than 30 mL per minute estimated
by the Cockroft-Gault equation), which would prevent the use of gadolinium enhancement

3. History of clinically significant (as determined by the investigator) cardiac,
endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
immunologic disease, or other major uncontrolled disease

4. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study

5. Prior history of suicide attempt at any time in the subject's lifetime prior to
signing the informed consent, or major psychiatric illness requiring hospitalization
within the last 3 years prior to signing the informed consent.

6. Pregnant or breast feeding

7. Active substance abuse or a history of substance abuse within 6 months prior to
screening

8. History of allergy or hypersensitivity to any component of the IP

9. History of rare hereditary problems of galactose intolerance, lapp lactase deficiency
or glucose-galactose malabsorption

10. History of positive human immunodeficiency virus (HIV), or congenital or acquired
immunodeficiency (eg, Common Variable Immunodeficiency Disease)

11. Active tuberculosis or a history of incompletely treated tuberculosis

12. Bacterial infections requiring treatment with oral or injectable antibiotics, or
significant viral or fungal infections, within 4 weeks of screening. Any treatment for
such infections must have been completed and the infection cured, at least 4 weeks
prior to screening and no new or recurrent infections prior to the Baseline Visit

13. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative
disease within the past 3 years, except for treated (ie, cured) basal cell or squamous
cell in situ skin carcinomas;

14. Major

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03783026

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03783026

Further information on trial

Date trial registered

14.12.2018

Incorporation of the first participant

29.01.2019

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A PHASE 4, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMPACT OF APREMILAST (CC-10004) MONOTHERAPY ON MRI OUTCOMES IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source of data: WHO)

Phase 4

Primary end point (Source of data: WHO)

Change from baseline in the composite score of BME, synovitis, and tenosynovitis assessed by Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS)

Secundary end point (Source of data: WHO)

Change from baseline in the Leeds Enthesitis Index (LEI), in subjects with preexisting enthesopathy;Proportion of subjects with baseline enthesitis whose enthesitis improves to 0;Change from baseline in the LDI, in subjects with preexisting dactylitis;Proportion of subjects with baseline dactylitis whose dactylitis count improves to 0;Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS);Change from baseline in the Evaluator's global assessment of disease activity;Change from baseline in the Subject's global assessment of disease activity;Change from baseline in the Subject's assessment of pain;Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI);Change from baseline in the WB-MRI Peripheral Enthesitis Inflammation Index;Change from baseline in the WB-MRI Peripheral Joints Inflammation Index;Change from baseline in the WB-MRI Total Peripheral Inflammation Index;Change from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Change from baseline in the Psoriatic Arthritis Impact of Disease 12 domains (PsAID-12);Adverse Events (AEs);Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC), in subjects with preexisting enthesopathy;Change from baseline in the Clinical Disease Activity Index for Psoriatic Arthritis (c-DAPSA) Score;Tender Joint Count (TJC);Swollen Joint Count (SJC);Change from baseline in bone proliferation/enthesophytes assessed by PsAMRIS;Change from baseline in bone erosion assessed by PsAMRIS;Change from baseline in the PsAMRIS total damage score;Change from baseline in periarticular inflammation assessed by PsAMRIS;Change from baseline in tenosynovitis assessed by PsAMRIS;Change from baseline in synovitis assessed by PsAMRIS;Change from baseline in BME assessed by PsAMRIS;Change from baseline in the PsAMRIS total inflammation score;Change from baseline in the composite score of BME and synovitis assessed by PsAMRIS;Change from baseline in the composite score of BME, synovitis, and tenosynovitis assessed by PsAMRIS

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Aarau, Genf, St Gallen

Countries (Source of data: WHO)

Austria, Belgium, Canada, Denmark, Germany, Italy, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Dr. Rüdiger Müller
+41 62 8384141
ruediger.mueller@ksa.ch

Contact for general information (Source of data: WHO)

Priscila Nakasato, MD
Celgene
1 (908) 442-6617
pnakasato@celgene.com

Contact for scientific information (Source of data: WHO)

Priscila Nakasato, MD
Celgene
1 (908) 442-6617
pnakasato@celgene.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Celgene

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-00617

Secondary ID (Source of data: WHO)

U1111-1223-9823;2018-002748-10;CC-10004-PSA-014