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Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis. (FOREMOST)

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ClinicalTrials.gov Identifier: NCT03747939
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 2 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 330 patients worldwide will take part in this study.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Apremilast (CC-10004) Other: Apremilast (CC-10004) Placebo Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or ≤1 Conventional Synthetic Disease-modifying Antirheumatic Drugs (DMARD).
Estimated Study Start Date : November 26, 2018
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD
Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Drug: Apremilast (CC-10004)
Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles.
Other Name: Otezla

Placebo Comparator: Placebo
Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
Other: Apremilast (CC-10004) Placebo
Subjects randomized to placebo will receive "dummy" dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles




Primary Outcome Measures :
  1. Proportion of subjects who achieved a clinical state of minimal disease activity defined MDA-Joints) [ Time Frame: Week 24 ]
    Minimal disease activity by MDA joints


Secondary Outcome Measures :
  1. Proportion of subjects with cDAPSA remission or low activity [ Time Frame: Week 24 ]
    cDAPSA Remission or Low Disease Activity

  2. Proportion of subjects with SJC ≤ 1 [ Time Frame: Week 24 ]
    Swollen Joint Count (SJC)

  3. Proportion of subjects with TJC ≤ 1 [ Time Frame: Week 24 ]
    Tender Joint Count (TJC)

  4. Proportion of subjects with improvement in the PsAID-12 score [ Time Frame: Week 24 ]
    PsAID-12 Response

  5. Proportion of subjects with improvement in the PASDAS score [ Time Frame: Week 24 ]
    PASDAS Response

  6. Proportion of subjects with improvement in the Patient Global Assessment of Disease Activity [ Time Frame: Week 24 ]
    Patient's Global Assessment of Disease Activity

  7. Proportion of subjects with improvement in the Patient Global Assessment Pain [ Time Frame: Week 24 ]
    Patient's Global Assessment of Disease Pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 yrs), male or female subject
  • Disease duration since diagnosis ≥ 3 months and ≤ 24 months as based on the Classification Criteria for Psoriatic Arthritis (CASPAR),
  • SJC AND TJC must be >1 and ≤ 4
  • For all regions, the local Regulatory Label for treatment with apremilast must be followed.
  • Stable doses of protocol-allowed PsA medications
  • General good health (except for psoriatic arthritis) 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).
  • Comply with protocol-required contraception measures

Exclusion Criteria:

  • Prior use of >1 as DMARD.
  • Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
  • Use of intra-articular (IA) glucocorticoid injection within 8 weeks before the Baseline Visit.
  • Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
  • Prior use of cyclosporine.
  • Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
  • Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747939


Contacts
Contact: Judith Maccarone, BSN 908-897-04134 jmaccarone@celgene.com
Contact: Arthur Czech 908-377-2094 aczech@celgene.com

Sponsors and Collaborators
Celgene
Investigators
Study Director: Priscila Nakasato, M.D Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03747939     History of Changes
Other Study ID Numbers: CC-10004-PSA-013
U1111-1224-0216 ( Registry Identifier: WHO )
2018-002735-26 ( EudraCT Number )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Oligoarthritis
PsA
Apremilast
Oral tablet
Background therapy
Standard of care

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Thalidomide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances