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NCT05683054
A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated
Phase 4 trial testing Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels in Psoriasis in 19 participants. Completed in 22 August 2022.
22 March 2022
Quick facts
| Lead sponsor | University Hospital, Ghent |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 11 August 2020 |
| Primary completion | 22 March 2022 |
| Estimated completion | 22 August 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels — full drug profile →
- Venapuncture
- Dermatology Life Quality Index (DLQI)
- EQ-5D-5L questionnaire
- Dried blood spot sampling
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
University Hospital, Ghent
Who can join
18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05683054
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University Hospital, Ghent trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05683054 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
- Last refreshed: 12 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05683054.
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