Psoriasis-Arthritis & Bone Program (PSARTROS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02483234|
Recruitment Status : Unknown
Verified June 2015 by University of Erlangen-Nürnberg Medical School.
Recruitment status was: Recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Psoriatic Arthritis||Drug: secukinumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Inflammatory and Structural Joint Damage in Patients With Psoriasis and Psoriatic Arthritis Treated With Secukinumab: A Phase 2, Single Arm, Single Centre Mode of Action Study (Psoriasis-Arthritis & Bone Program, PSARTROS)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Psoriasis/Psoriatic arthritis
Patients with Psoriasis and inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan will be treated with Secukinumab. Patients with psoriatic arthritis will be treated with Secukinumab. Bone changes will be evaluated influenced by IL-17 blockade
- The improvement of the PsAMRIS synovitis score [ Time Frame: baseline to week 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483234
|University of Erlangen-Nuremberg||Recruiting|
|Erlangen, Germany, 91054|
|Contact: Axel Hueber, MD PhD 00499131 ext 8536925 firstname.lastname@example.org|