UveitisPhase 1/2NCT00889421
Apremilast in the Treatment of Uveitis
A Phase 1/2 study testing Apremilast in people with Uveitis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients with vision-threatening autoimmune uveitis
- failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
Who cannot join
- serious concomitant illness that could interfere with the subject's participation
- previous or current use of an alkylating agent
- use of CYP3A4 inhibitors during the trial
- TNF blocker use within the 8 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
- Conditions
- Uveitis
- Being tested
- Apremilast
- Keywords
- uveitis, apremilast
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
oral dose of 30 mg BID for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receiving apremilast. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Measured: 6 months
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Measured: 6 months
Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)
Measured: 6 months
Reduction in Cystoid Macular Edema
Measured: 6 months
Secondary outcomes (1)
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Investigator discretion due to lack of efficacy in three subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Eric B. Suhler, Oregon Health and Science University
- Investigators
- Eric B Suhler, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889421
- Sponsor's protocol ID
- e4235
- Status last verified
- Jun 2014
- First submitted
- 24 Apr 2009
- Last updated
- 8 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.
- ClinicalTrials.gov ID
- NCT00889421
- Acronym / sponsor ID
- e4235
- Conditions
- Uveitis
- Keywords
- uveitis, apremilast
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator discretion due to lack of efficacy in three subjects enrolled
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 8 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: ApremilastPatients receiving apremilast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with vision-threatening autoimmune uveitis
- failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
Key exclusion criteria (4 listed)
- serious concomitant illness that could interfere with the subject's participation
- previous or current use of an alkylating agent
- use of CYP3A4 inhibitors during the trial
- TNF blocker use within the 8 weeks prior to enrollment
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 |
|---|---|---|
| Apremilastoral dose of 30 mg BID for 6 months | Drug | Treatment |
Primary outcome
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Time frame: 6 months
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Time frame: 6 months
Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)
Time frame: 6 months
Reduction in Cystoid Macular Edema
Time frame: 6 months
1 secondary outcome
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eric B Suhler, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apremilast in people with Uveitis, run by Oregon Health and Science University 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Jul 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye (time frame: 6 months). The study lists 4 primary outcomes in all. 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 8 Jul 2014.