UveitisPhase 3SUPPORTNCT01327664
Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis
A Phase 3 study testing AIN457 in people with Uveitis, run by Novartis Pharmaceuticals.
Trial summary
This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- AIN457
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2014
- 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
- Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed
- Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1)
- Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator
Who cannot join
- Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457
- Pregnant or nursing (lactating) women
- Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis
This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.
- Conditions
- Uveitis
- Being tested
- AIN457
- Keywords
- Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
- Medical subject headings
- Uveitis, Uveitis, Intermediate, Panuveitis, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Biological
| Study group | Role | What they receive |
|---|---|---|
| AIN457 300mg s.c every 2 weeks | Experimental | Not described Receives: Biological: AIN457 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with adverse events as a measure of safety and tolerability
Measured: up to 36 months
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
Measured: up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis
Measured: up to 36 months
Secondary outcomes (3)
Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment
Measured: up to 36 months
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment
Measured: up to 36 months
Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014 (estimated)
Why it stopped: Study will not be initiated as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327664
- Sponsor's protocol ID
- CAIN457C2399
- Other IDs
- 2010-021239-15
- Acronym
- SUPPORT
- Status last verified
- Dec 2013
- First submitted
- 24 Feb 2011
- Last updated
- 6 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis
- ClinicalTrials.gov ID
- NCT01327664
- Acronym / sponsor ID
- SUPPORT / CAIN457C2399
- Conditions
- Uveitis
- Keywords
- Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will not be initiated as planned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2014 (estimated)
- First posted
- 1 Apr 2011 (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.
This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIN457 300mg s.c every 2 weeks | Experimental | Biological: AIN457 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed
- Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1)
- Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator
Key exclusion criteria (4 listed)
- Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457
- Pregnant or nursing (lactating) women
- Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| AIN457 | Biological | AIN457 300mg s.c every 2 weeks |
Primary outcome
Participants with adverse events as a measure of safety and tolerability
Time frame: up to 36 months
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
Time frame: up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis
Time frame: up to 36 months
3 secondary outcomes
Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment
Time frame: up to 36 months
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment
Time frame: up to 36 months
Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457
Time frame: up to 36 months
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 6 Dec 2013.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AIN457 in people with Uveitis, run by Novartis Pharmaceuticals.
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 3 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: withdrawn, as of the sponsor's last update on 6 Dec 2013. 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?
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?
Participants with adverse events as a measure of safety and tolerability (time frame: up to 36 months). The study lists 3 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 6 Dec 2013.