Psoriatic ArthritisPhase 4NCT02558361
Treatment With Apremilast in Patients With Psoriatic Arthritis
A Phase 4 study testing Treatment with Apremilast in people with Psoriatic Arthritis, run by University of South Florida at 1 site in United States.
Trial summary
Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Treatment with Apremilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Must be in general good health (except for psoriatic arthritis and psoriasis) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Patients at least 18 years of age with PsA (must meet CASPAR Criteria) and PsO.
- Active knee synovitis (target joint)
- Active psoriatic plaque (target skin lesion)
- Not currently taking or previously on Otezla
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- Cannot be on concurrent biologics
- Females of childbearing potential (FCBP)† must have a negative pregnancy test at Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage 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 (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex 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.
- Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
- † A female of childbearing potential is 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 randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Other than psoriatic arthritis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
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- Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with apremilast.
- Currently treated with a biologic (TNFi)
- Standard exclusions for treatment or biopsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Morsani Center for Advanced healthcare
Tampa, Florida, 33612
About this study
Official title: A Skin and Synovial Tissue Assessment of Overlapping Genes and Their Response After 3 Months Treatment With Apremilast in Patients With Psoriatic Arthritis
Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.
Read the detailed description
Purpose of the study Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin. They also provide no data regarding the timing of response in the target organs.
Because of these limitations in the existing literature, a study assessing the response to apremilast in synovial (joint) tissue and skin is needed. This will be a small study assessing the inflammatory response in the synovial (joint) tissue and skin samples from patients with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
We are asking you to take part in this research study because you have both psoriasis and psoriatic arthritis. Both conditions are active and you are an appropriate candidate to be treated with apremilast, i.e. this same treatment would be offered to you if you were not to enroll in this study. You are also an appropriate candidate to receive skin and synovial (joint) tissue biopsies. We want to find out how specific proteins in your skin and synovial (joint) tissue that are responsible for the inflammation associated with psoriasis and psoriatic arthritis respond to treatment with apremilast.
Study Procedures: What will happen during this study?
This study will consist of three study visits over a period of three months. If appropriate, you will be started on apremilast at your first study visit. This is part of your standard of care. The dose of apremilast you will receive will be the normal FDA-approved dose. You will not receive a placebo (sugar) pill. Everyone who participates in the study will be treated with apremilast. The study procedures that will take place at each of the three visits are listed below:
Baseline Visit:
Review inclusion/exclusion criteria Medical history obtained by the study nurse A physical examination by the study doctor Obtain blood and urine samples with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
- Conditions
- Psoriatic Arthritis
- Being tested
- Treatment with Apremilast
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with ApremilastDrug
Also called Otezla
Standard dosing with apremilast (Otezla) will be used. [30mg po BID after initial titration]
| Study group | Role | What they receive |
|---|---|---|
| Open label, single arm | Other | Baseline visit:assess disease activity,synovial tissue biopsy of the knee with active synovitis [target joint] and punch skin biopsy of a target psoriatic plaque. Perform a similar punch skin biopsy on adjacent normal skin. Start apremilast (standard dosing). Perform venipuncture: blood samples will be obtained for routine studies, quantitative RT-PCR \& ex vivo cytokine production assays. UA/pregnancy test.
Month 1: assess disease active , monitor for AE's; repeat punch skin biopsy of target psoriatic plaque. Blood samples will be obtained for RT-PCR and ex vivo cytokine production assays.
Month 3: same as month 1; repeat synovial tissue biopsy from target knee joint and punch skin biopsy on target psoriatic plaque. Blood samples for RT-PCR ex vivo cytokine production assays and routine studies. Receives: Drug: Treatment with Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change in the specific 32 gene products as measured by RT-PCR from baseline to Month 3 on synovial, skin samples (Co-primary endpoints) using the sign test.
Measured: To be assessed by a change from baseline to month three
Secondary outcomes (1)
Comparison of the change in the RT-PCR gene products from baseline to Month 3 on blood samples (sign test).
Measured: To be assessed by a change from baseline to month three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: FDA approved synovial biopsy device unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John D Carter, MD, Principal investigator, University of South Florida Morsani College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558361
- Sponsor's protocol ID
- PRO00023672
- Status last verified
- Jun 2016
- First submitted
- 16 Sep 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Skin and Synovial Tissue Assessment of Overlapping Genes and Their Response After 3 Months Treatment With Apremilast in Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT02558361
- Acronym / sponsor ID
- PRO00023672
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA approved synovial biopsy device unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Sep 2015 (estimated)
- 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.
Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.
Detailed description
Purpose of the study Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis.
Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin. They also provide no data regarding the timing of response in the target organs.
Because of these limitations in the existing literature, a study assessing the response to apremilast in synovial (joint) tissue and skin is needed. This will be a small study assessing the inflammatory response in the synovial (joint) tissue and skin samples from patients with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
We are asking you to take part in this research study because you have both psoriasis and psoriatic arthritis. Both conditions are active and you are an appropriate candidate to be treated with apremilast, i.e. this same treatment would be offered to you if you were not to enroll in this study. You are also an appropriate candidate to receive skin and synovial (joint) tissue biopsies. We want to find out how specific proteins in your skin and synovial (joint) tissue that are responsible for the inflammation associated with psoriasis and psoriatic arthritis respond to treatment with apremilast.
Study Procedures: What will happen during this study?
This study will consist of three study visits over a period of three months. If appropriate, you will be started on apremilast at your first study visit. This is part of your standard of care. The dose of apremilast you will receive will be the normal FDA-approved dose. You will not receive a placebo (sugar) pill. Everyone who participates in the study will be treated with apremilast. The study procedures that will take place at each of the three visits are listed below:
Baseline Visit:
Review inclusion/exclusion criteria Medical history obtained by the study nurse A physical examination by the study doctor Obtain blood and urine samples with psoriatic arthritis and psoriasis. These data will be very important in demonstrating the effect of apremilast on the target organ tissues; i.e. synovial (joint) tissue and skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label, single arm | Other | Drug: Treatment with ApremilastBaseline visit:assess disease activity,synovial tissue biopsy of the knee with active synovitis [target joint] and punch skin biopsy of a target psoriatic plaque. Perform a similar punch skin biopsy on adjacent normal skin. Start apremilast (standard dosing). Perform venipuncture: blood samples will be obtained for routine studies, quantitative RT-PCR \& ex vivo cytokine production assays. UA/pregnancy test. Month 1: assess disease active , monitor for AE's; repeat punch skin biopsy of target psoriatic plaque. Blood samples will be obtained for RT-PCR and ex vivo cytokine production assays. Month 3: same as month 1; repeat synovial tissue biopsy from target knee joint and punch skin biopsy on target psoriatic plaque. Blood samples for RT-PCR ex vivo cytokine production assays and routine studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be in general good health (except for psoriatic arthritis and psoriasis) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Patients at least 18 years of age with PsA (must meet CASPAR Criteria) and PsO.
- Active knee synovitis (target joint)
- Active psoriatic plaque (target skin lesion)
- Not currently taking or previously on Otezla
Key exclusion criteria (12 listed)
- The presence of any of the following will exclude a subject from enrollment:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
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 |
|---|---|---|
| Treatment with ApremilastAlso: OtezlaStandard dosing with apremilast (Otezla) will be used. [30mg po BID after initial titration] | Drug | Open label, single arm |
Primary outcome
Comparison of the change in the specific 32 gene products as measured by RT-PCR from baseline to Month 3 on synovial, skin samples (Co-primary endpoints) using the sign test.
Time frame: To be assessed by a change from baseline to month three
1 secondary outcome
Comparison of the change in the RT-PCR gene products from baseline to Month 3 on blood samples (sign test).
Time frame: To be assessed by a change from baseline to month three
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: No
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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.
John D Carter, MD principal investigator
University of South Florida Morsani College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with Apremilast in people with Psoriatic Arthritis, run by University of South Florida at 1 site in United States.
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 12 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the change in the specific 32 gene products as measured by RT-PCR from baseline to Month 3 on synovial, skin samples (Co-primary endpoints) using the sign test. (time frame: To be assessed by a change from baseline to month three). 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 21 Oct 2016.