UveitisNCT00404482
Cyclosporine A in the Treatment of Juvenile Idiopathic Arthritis (JIA) Associated Chronic Anterior Uveitis
An observational study of Uveitis and Juvenile Idiopathic Arthritis, run by St. Franziskus Hospital at 3 sites in Germany.
Trial summary
Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis. Presence of vision threatening complications may indicate immunosuppressive therapy. In this study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Uveitis, Juvenile Idiopathic Arthritis
- What is being tested?
- Cyclosporine A
- How many people
- 60 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 1991to Aug 2006
- Phase
- Observational
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: patients with JIA and cyclosporin A therapy
Who may be able to join
- uveitis
- JIA
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Deutsches Zentrum für Kinder- und Jugendrheumatologie
Garmisch-Partenkirchen
Department of Ophthalmology at St.-FranziskusHospital
Münster
Kinder und Jugendrheumatologie St. Josef Stift
Sendenhorst
About this study
Official title: Efficacy and Adverse Effects of Cyclosporine A in the Treatment of Chronic Anterior Uveitis in Patients With Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis. Presence of vision threatening complications may indicate immunosuppressive therapy. In this study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.
- Conditions
- Uveitis, Juvenile Idiopathic Arthritis
- Being tested
- Cyclosporine A
- Keywords
- uveitis, jia, Cyclosporine A, MTX
- Medical subject headings
- Uveitis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startJan 1991
- Study completionAug 2006
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Tappeiner, MD, Principal investigator, Department of Ophthalmology at University Bern - Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404482
- Sponsor's protocol ID
- 01-1106
- Status last verified
- Jun 2009
- First submitted
- 27 Nov 2006
- Last updated
- 3 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Adverse Effects of Cyclosporine A in the Treatment of Chronic Anterior Uveitis in Patients With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT00404482
- Acronym / sponsor ID
- 01-1106
- Conditions
- Uveitis, Juvenile Idiopathic Arthritis
- Keywords
- uveitis, jia, Cyclosporine A, MTX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- Jan 1991
- Study completion
- Aug 2006
- First posted
- 28 Nov 2006 (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.
Juvenile idiopathic arthritis (JIA) is often associated with chronic anterior uveitis. Presence of vision threatening complications may indicate immunosuppressive therapy. In this study, the experience with cyclosporine A (CsA) as mono- or combination-therapy is analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with JIA and cyclosporin A therapy
Key inclusion criteria (2 listed)
- uveitis
- JIA
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cyclosporine A | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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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.
Christoph Tappeiner, MD principal investigator
Department of Ophthalmology at University Bern - Inselspital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Juvenile Idiopathic Arthritis, run by St. Franziskus Hospital at 3 sites in Germany.
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 0 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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Jun 2009.