Objectives1. Determine efficacy of adalimumab as the first biologic agent or after previous use of other anti-TNF blocking agent. Efficacy will be evaluated by means of the ASAS 20% response criteria.2. Determine the efficacy of adalimumab on…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary:
- ASAS 20% response
- occurrence of attacks of uveitis.
Secondary outcome
Secondary: adverse events, improvement of mobility, swollen joints,
inflammatory markers, and radiographic progression.
Background summary
Until recently, there were only few therapeutic options to treat AS. Efficacy
is only proven for treatment with NSAIDs and in some cases sulphasalazine. TNF
blocking agents, like etanercept and infliximab are very effective in these
patients. However, the efficacy on extra spinal manifestations as uveitis
appear to differ between these drugs, with a better efficacy, i.e. less
(severe) attacks with infliximab in comparison to etanercept.
The efficacy of adalimumab on uveitis has not yet been investigated. These
attacks of anterior uveitis occur frequently in AS and up to 30% of the
patients suffer from uveitis and ultimately it can result in glaucoma and
severe visual impairment if left untreated.
Adalimumab is another TNF-blocking agent which is currently investigated in
several clinical trials for ankylosing spondylitis. Ongoing studies indicate
that adalimumab is effective in AS. and recently adalimumab is registered for.
This study aims to monitor the efficacy on AS and the extra spinal
manifestations like uveitis.
Study objective
Objectives
1. Determine efficacy of adalimumab as the first biologic agent or after
previous use of other anti-TNF blocking agent. Efficacy will be evaluated by
means of the ASAS 20% response criteria.
2. Determine the efficacy of adalimumab on uveitis.
3. Determine safety of adalimumab by monitoring of adverse events.
Study design
Methods
The visits occur at screening, baseline, 4, 12 weeks, and every 3 months
thereafter. The follow-up period is aimed to reach at least between one and
three years.
During the follow-up the following parameters will be measured:
Every visit: registration of adverse events, occurrence of extra-spinal
manifestations, physical examination (joint assessments a.o.), questionnaires
and laboratory tests.
At baseline and every 6 months a screening by the ophthalmologist will be
performed with special attential for uveitis. will be compared with the
historical controls (the attacks per year before therapy
Study burden and risks
None, exept a limited extra amount of blood, obtained during regular
venapuntures
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Ankylosing spondylitis according to the modified New York criteria, who will start with adalimumab.
Exclusion criteria
1. Persistent chronic or active infections
2. History of amlignancy
3. Immuno-compromised conditions.
4. History of central nervous system (CNS) demyelinating disease.
5. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
6. Known history of allergic reaction or significant hypersensitivity to the constituents of adalimumab.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006770-13-NL |
| CCMO | NL15746.048.06 |