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Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a Joint-periarticular-nail Ultrasound Index in Patients With Active Psoriatic Arthritis (APREMILAST)

This study is not yet open for participant recruitment.
Verified June 2017 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03191539
First Posted: June 19, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
  Purpose

This study aims to evaluate more objectively, through an imaging technique such as ultrasound, changes in joints and entheses of patients with active psoriatic arthritis (PAs) who will start treatment with Apremilast after the failure of other therapies such as synthetic DMARD (metrotrexato , Leflunomide ...).

The hypothesis of the study is that the technique of ultrasound can demonstrate the efficacy of Apremilast in the treatment of patients with active PAs


Condition Intervention Phase
Arthritis; Psoriasis (Etiology) Drug: Apremilast Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Clinical and Ultrasound Response to Apremilast by Clinical Evaluation and by a Joint-periarticular-nail Ultrasound Index in Patients With Active Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Reduction in the ultrasound index [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
    Reduction in the ultrasound index at 12 months after the introduction of Apremilast in the study patients


Secondary Outcome Measures:
  • Disease Activity Score (DAS 28) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Psoriasis activity and severity index (PASI) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Leeds Enthesitis Index (LEI) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Number of tender and swollen joints assessed by (Number of Tender Joints (NTJ) ) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Patient Visual Analog Scale (VAS) for pain [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Ultrasonic nail injuries [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Clinical Disease Activity Index (CDAI) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Simple Disease Activity Index (SDAI) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • Number of tender and swollen joints assessed by (Number os swollen joints (NSJ)) [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]
  • doctor Visual Analog Scale (VAS) for pain [ Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months ]

Estimated Enrollment: 56
Anticipated Study Start Date: November 2, 2017
Estimated Study Completion Date: June 14, 2019
Estimated Primary Completion Date: June 14, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast
30 mg of Apremilast twice a day during 52 weeks. During the first 6 days will be a dose escalation as the following: Day 1: 10 mg daily Day 2: 10 mg day- 10 mg night Day 3: 10 mg day- 20 mg night Day 4: 20mg day- 20mg night Day 5: 20 mg day- 30 mg night Day 6: 30 mg day- 30 mg night
Drug: Apremilast
30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adults 18 years of age or older with Psoriatic Arthritis (PsA) according to Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at the time of selection, with involvement of hands and/or feet with active clinical disease (more than two swollen joints)
  • Present 2 or more joints with ultrasound synovitis at the screening visit
  • Present 1 or more entheses affected as shown by ultrasound at the screening visit
  • Accept and sign the informed consent of the study
  • Ability to comply with all tests and visits of specified protocol and have a permanent address.
  • Women of childbearing potential must have a negative pregnancy test at the baseline visit. Women of childbearing potential who participate in the study should use one of the following contraceptive methods throughout the trial and for at least 28 days after taking the last dose of study medication.
  • Approved contraceptive options are:

Option 1: Any of the following: hormonal contraceptives (e.g., birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or her partner has had a vasectomy OR Option 2: Male or female condom (a latex condom or non-latex condom but NOT made of natural membrane [animal, e.g., polyurethane]) AND one of the following additional barrier methods: a) diaphragm with spermicide; B) cervical cap with spermicide; or c) contraceptive sponge with spermicide.

Exclusion Criteria:

  • Concomitant treatment with methotrexate or leflunomide or other DMARDs. Patients may not have taken methotrexate during the month prior to screening, leflunomide during the 2 months prior to screening and other DMARDs during the 15 days prior to screening
  • Prior or current use of biological therapy (anti-TNF)
  • Failure to meet any of the inclusion requirements
  • Medical contraindications for taking Apremilast
  • Pregnancy or breastfeeding
  • History of allergy to any component of the study drug
  • Active tuberculosis (TB) or history of incomplete treatment for tuberculosis
  • Substance abuse or history of substance abuse within 6 months prior to screening
  • Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks prior to screening
  • Malignancy or history of malignancy (except in situ basal or squamous cell skin carcinomas treated [i.e., cured] and treated cervical intraepithelial neoplasms [i.e., cured] or carcinoma in situ of the cervix without evidence of recurrence within the last 5 years)
  • Use of systemic corticosteroids at doses >10 mg/day at the time of screening and 4 weeks before
  • Use of potent cytochrome CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's wort and grapefruit juice) at the time of screening, 4 weeks before or during the study
  • Use of phototherapy within 4 weeks prior to screening (i.e., Ultraviolet B (UVB), psoralen and ultraviolet A (PUVA))
  • Use of any investigational drug within 4 weeks prior to screening
  • Prior treatment with Apremilast
  Contacts and Locations
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): NCT03191539


Contacts
Contact: Juan José de Agustín de Oro, MD 93 489 30 00 jjdagust@vhebron.net

Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Celgene Corporation
  More Information

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03191539     History of Changes
Other Study ID Numbers: PSA‐PI‐006421
First Submitted: June 13, 2017
First Posted: June 19, 2017
Last Update Posted: October 17, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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