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)

October 16, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease Activity Score (DAS 28)
Time Frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
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
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
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
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
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
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
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
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
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
screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSA-PI-006421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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