UveitisPhase 2NCT01279954
Abatacept in the Treatment of Uveitis
A Phase 2 study testing Abatacept 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 abatacept in the treatment of uveitis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2017
- Phase
- Phase 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 6 years and older
- All sexes
- No healthy volunteers
- Child, 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
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 Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
- Conditions
- Uveitis
- Being tested
- Abatacept
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called orencia
Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| open-label abatacept first, then 5 mg/kg abatacept | Experimental | 10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months) Receives: Drug: Abatacept |
| open-label abatacept first, then 10 mg/kg abatacept | Experimental | 10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months) Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
number of participants with adverse events
Measured: 2 years
Secondary outcomes (3)
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity
improvement by 2 or more lines of best-corrected visual acuity With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.
Measured: Week 24
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.
Measured: Week 24
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods
Reduction of AC cellular activity and/or vitreous haze by 2 grades. Reduction of chorioretinal infiltrates or reduction of retinal vasculitis. Reduction of cystoid macular edema and/or retinal inflammation. With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionJun 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Eric B. Suhler, Oregon Health and Science University
- Investigators
- Eric B. Suhler, MD, MPH, Principal investigator, Oregon Health and Science UniversityJames T Rosenbaum, MD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279954
- Sponsor's protocol ID
- e7035
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2011
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
- ClinicalTrials.gov ID
- NCT01279954
- Acronym / sponsor ID
- e7035
- Conditions
- Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Posted 21 Feb 2019
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 abatacept in the treatment of uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open-label abatacept first, then 5 mg/kg abatacept | Experimental | Drug: Abatacept10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months) |
| open-label abatacept first, then 10 mg/kg abatacept | Experimental | Drug: Abatacept10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 (1 listed)
- serious concomitant illness that could interfere with the subject's participation
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 |
|---|---|---|
| AbataceptAlso: orenciaSubjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg. Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years. | Drug | open-label abatacept first, then 10 mg/kg abatacept, open-label abatacept first, then 5 mg/kg abatacept |
Primary outcome
Adverse Events
Time frame: 2 years
number of participants with adverse events
3 secondary outcomes
Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity
Time frame: Week 24
Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Time frame: Week 24
Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- 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
James T Rosenbaum, MD study director
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 2 study testing Abatacept 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 1 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: finished, as of the sponsor's last update on 21 Feb 2019. 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 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 21 Feb 2019). 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?
Adverse Events (time frame: 2 years). 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 Feb 2019.