drugset / Trial / NCT02483234
Psoriasis-Arthritis & Bone Program
NaSingle-groupOpen-labelTreatment
Summary
Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions in psoriasis patients and patients with PsA. Primary Objective is the improvement of the PsAMRIS synovitis score baseline vs. week 24. Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic arthritis (PsA).
Timeline
- Start
- 2015-05-31
- Primary completion
- 2018-06-30
- Completion
- 2018-09-30
Publications
- Kampylafka E, Tascilar K, Lerchen V, Linz C, Sokolova M, Zekovic A, Kleyer A, Simon D, Rech J, Sticherling M, Schett G, Hueber AJ. Secukinumab leads to shifts from stage-based towards response-based disease clusters-comparative data from very early and established psoriatic arthritis. Arthritis Res Ther. 2020 Sep 9;22(1):207. doi: 10.1186/s13075-020-02268-y.
- Kampylafka E, Simon D, d'Oliveira I, Linz C, Lerchen V, Englbrecht M, Rech J, Kleyer A, Sticherling M, Schett G, Hueber AJ. Disease interception with interleukin-17 inhibition in high-risk psoriasis patients with subclinical joint inflammation-data from the prospective IVEPSA study. Arthritis Res Ther. 2019 Jul 26;21(1):178. doi: 10.1186/s13075-019-1957-0.
- Kampylafka E, d'Oliveira I, Linz C, Lerchen V, Stemmler F, Simon D, Englbrecht M, Sticherling M, Rech J, Kleyer A, Schett G, Hueber AJ. Resolution of synovitis and arrest of catabolic and anabolic bone changes in patients with psoriatic arthritis by IL-17A blockade with secukinumab: results from the prospective PSARTROS study. Arthritis Res Ther. 2018 Jul 27;20(1):153. doi: 10.1186/s13075-018-1653-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |