Arthritis; Psoriasis (Etiology)Phase 3APREMILASTNCT03191539
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
A Phase 3 study testing Apremilast in people with Arthritis; Psoriasis (Etiology), run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
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 ...). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis; Psoriasis (Etiology)
- What is being tested?
- Apremilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2017to 14 Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Arthritis; Psoriasis (Etiology)
- Being tested
- Apremilast
- Medical subject headings
- Arthritis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | 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 Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the ultrasound index
Reduction in the ultrasound index at 12 months after the introduction of Apremilast in the study patients
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Secondary outcomes (10)
Disease Activity Score (DAS 28)
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Psoriasis activity and severity index (PASI)
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Leeds Enthesitis Index (LEI)
Measured: 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) )
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Patient Visual Analog Scale (VAS) for pain
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Ultrasonic nail injuries
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Clinical Disease Activity Index (CDAI)
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Simple Disease Activity Index (SDAI)
Measured: 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))
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
doctor Visual Analog Scale (VAS) for pain
Measured: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start2 Nov 2017 (estimated)
- Primary completion14 Jun 2019 (estimated)
- Study completion14 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis; Psoriasis (Etiology)Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191539
- Sponsor's protocol ID
- PSA-PI-006421
- Acronym
- APREMILAST
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03191539
- Acronym / sponsor ID
- APREMILAST / PSA-PI-006421
- Conditions
- Arthritis; Psoriasis (Etiology)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 2 Nov 2017 (estimated)
- Primary completion
- 14 Jun 2019 (estimated)
- Study completion
- 14 Jun 2019 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: Apremilast30 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apremilast30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation | Drug | Apremilast |
Primary outcome
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Arthritis; Psoriasis (Etiology), run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan José de Agustín de Oro, MD (93 489 30 00, jjdagust@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the ultrasound index (time frame: screening visit, baseline visit, visit 1 month, visit 6 months, visit 9 months and visit 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.