A Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects With Psoriatic Arthritis

Study Purpose

This is a Phase 4, multicenter, single-arm, open-label study to evaluate the impact of apremilast, either in monotherapy or with stable Methotrexate (MTX), on Magnetic resonance imaging (MRI) outcomes in subjects with active PsA with up to 5 years of disease duration (since diagnosis).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following Baseline Visit. 15. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia. 16. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease), which confounds the ability to interpret data from the study. 17. Prior treatment with any biologic DMARD. 18. Prior treatment with more than 2 csDMARDs. 19. Use of the following systemic therapy(ies) within 28 days of the Baseline Visit (ie, Visit 2, Day 1): cyclosporine or other calcineurin inhibitors, glucocorticoids exceeding 10 mg daily prednisone equivalent, as well as mycophenolate. 20. Use of MTX within 4 weeks of the Baseline Visit (ie, Visit 2, Day 1), unless subject is on. 21. Use of LEF within 12 weeks of the Baseline Visit (ie, Visit 2, Day 1), unless subject has taken cholestyramine, 8 g three times daily 11 days after stopping LEF. 22. Previous treatment with a JAK inhibitor (including tyk2 inhibitor) 23. Prior treatment with apremilast, or participation in a clinical study involving apremilast. 24. Use of intra-articular (IA) glucocorticoid injection within 8 weeks before the Baseline Visit (ie, Visit 2, Day 1). 25. Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03783026
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, Denmark, Germany, Italy, Russian Federation, Spain, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Study Website: View Trial Website
Additional Details

Approximately 120 subjects will receive apremilast 30 mg BID, after a 5-day titration period, with or without MTX. All subjects will be permitted to take NSAIDs and/or low-dose oral glucocorticoids (prednisone ≤ 10 mg/day or equivalent) throughout the study. The NSAIDs and low-dose oral glucocorticoids must be on a stable regimen for at least 4 weeks prior to baseline. MTX (≤ 25 mg/week) will be permitted if treatment duration is ≥ 6 months and on a stable regimen for at least 3 months prior to baseline. In addition, Nonsteroidal anti-inflammatory drug (NSAIDs), and low-dose glucocorticoids must be continued from Day 1 through the Week 24 Visit. Change in doses, increase or decrease, and/or discontinuation will not be allowed, except for safety reasons or for lack of availability. After the Week 24 Visit, the doses of MTX, NSAIDs, or glucocorticoids may be adjusted as clinically required.

Arms & Interventions

Arms

Experimental: Administration of CC-10004

Apremilast 30 mg BID in monotherapy or in combination with Methotrexate

Interventions

Drug: - CC-10004

CC-10004

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Santa Monica, California

Status

Recruiting

Address

Research Site

Santa Monica, California, 90404

Research Site, Upland, California

Status

Recruiting

Address

Research Site

Upland, California, 91786

Research Site, Gainesville, Florida

Status

Recruiting

Address

Research Site

Gainesville, Florida, 32610

Research Site, Plantation, Florida

Status

Recruiting

Address

Research Site

Plantation, Florida, 33324

Research Site, New York, New York

Status

Recruiting

Address

Research Site

New York, New York, 10003

Research Site, Austin, Texas

Status

Recruiting

Address

Research Site

Austin, Texas, 78731

Research Site, Seattle, Washington

Status

Recruiting

Address

Research Site

Seattle, Washington, 98104

International Sites

Research Site, Vienna, Austria

Status

Recruiting

Address

Research Site

Vienna, , 1090

Research Site, Leuven, Belgium

Status

Recruiting

Address

Research Site

Leuven, , 3000

Research Site, Calgary, Alberta, Canada

Status

Completed

Address

Research Site

Calgary, Alberta, T2N 4N1

Research Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Research Site

Edmonton, Alberta, T5M 0H4

Research Site, Ottawa, Ontario, Canada

Status

Recruiting

Address

Research Site

Ottawa, Ontario, K1H 7W9

Research Site, Quebec, Canada

Status

Recruiting

Address

Research Site

Quebec, , G1V 3M7

Research Site, Aalborg, Denmark

Status

Recruiting

Address

Research Site

Aalborg, , 9000

Research Site, Frederiksberg, Denmark

Status

Recruiting

Address

Research Site

Frederiksberg, , 2000

Research Site, Glostrup, Denmark

Status

Recruiting

Address

Research Site

Glostrup, , 2600

Research Site, Bonn, Germany

Status

Recruiting

Address

Research Site

Bonn, , 53127

Research Site, Duesseldorf, Germany

Status

Recruiting

Address

Research Site

Duesseldorf, , 40225

Research Site, Frankfurt am Main, Germany

Status

Recruiting

Address

Research Site

Frankfurt am Main, , 60590

Research Site, Catania, Italy

Status

Recruiting

Address

Research Site

Catania, , 95123

Research Site, Potenza/Matera, Italy

Status

Recruiting

Address

Research Site

Potenza/Matera, , 85100

Research Site, Izhevsk, Russian Federation

Status

Recruiting

Address

Research Site

Izhevsk, , 426009

Research Site, Moscow, Russian Federation

Status

Recruiting

Address

Research Site

Moscow, , 115522

Research Site, Novosibirsk, Russian Federation

Status

Recruiting

Address

Research Site

Novosibirsk, , 630061

Research Site, Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Research Site

Saint-Petersburg, , 191015

Research Site, Tyumen, Russian Federation

Status

Recruiting

Address

Research Site

Tyumen, , 625032

Research Site, Sevilla, Andalucía, Spain

Status

Recruiting

Address

Research Site

Sevilla, Andalucía, 41009

Research Site, Barcelona, Spain

Status

Recruiting

Address

Research Site

Barcelona, , 08041

Research Site, Madrid, Spain

Status

Recruiting

Address

Research Site

Madrid, , 28046

Research Site, Aarau, Switzerland

Status

Recruiting

Address

Research Site

Aarau, , 5001

Research Site, Geneve, Switzerland

Status

Recruiting

Address

Research Site

Geneve, , 1206

Research Site, Sankt Gallen, Switzerland

Status

Recruiting

Address

Research Site

Sankt Gallen, , 9007

Research Site, Edinburgh, United Kingdom

Status

Recruiting

Address

Research Site

Edinburgh, , EH16 4TJ

Research Site, Leeds, United Kingdom

Status

Recruiting

Address

Research Site

Leeds, , LS7 4SA

Research Site, Southampton, United Kingdom

Status

Recruiting

Address

Research Site

Southampton, , SO16 6YD