Mechanism of Action of Ustekinumab in Psoriatic Arthritis

NCT03565042 | Unknown

• 1 other identifier: AMC_50218_MoA anti-p40
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the mechanism of action on target tissue level of ustekinumab treatment in psoriatic arthritis patients. Patients who are planning to start treatment with anti-p40 therapy (ustekinumab) will be included in the trial. At week 0, 12 and 24 peripheral blood, synovial tissue and skin will be obtained and analysed with different techniques to assess the effect of the therapy on inflammatory pathways.

Conditions

Arthritis, Psoriatic

Keywords

Arthritis, Psoriatic; Mechanism of Action; Ustekinumab; anti-p40; anti-IL23/Il12 p40

Outcome Measures

Primary Outcomes (1)

• Biological effect of treatment on synovium obtained via arthroscopy from a swollen knee or ankle.

  Cellular and molecular changes of the synovium.

  Cellular and molecular changes of the synovium of samples obtained at week 0 compared with week 12 and week 24.

Other Outcomes (1)

• biological effect of anti TNF v.s. anti IL23/IL12 p40 on synovium obtained from a swollen knee or ankle.

  week 0 compared with week 12 and week 24

Study Arms (1)

MoA ustekinumab

Patients with a diagnosis of psoriatic arthritis according to the CASPAR criteria with at least one swollen knee or ankle joint who are planning to receive treatment with ustekinumab at the outpatient clinic. An arthroscopy will be done in the swollen knee/ankle at week 0, 12 and 24.

Procedure: Arthroscopy

Interventions

Arthroscopy PROCEDURE

Arthroscopy of swollen joint (ankle/knee)

MoA ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of psoriatic arthritis according to the CASPAR criteria with at least one swollen knee or ankle joint who are planning to receive treatment with ustekinumab at the outpatient clinic. In total 16 patients will be included.

You may qualify if:

• Male and female patients age \> 18 years diagnosed with Psoriatic Arthritis according to the CASPAR criteria
• Patient for whom the treating physician has decided to prescribe in the usual manner: Ustekinumab (Stelara) (45mg/ injection, given on week 0, 4, and every 12 weeks thereafter)
• Active disease defined by ≥1 swollen and ≥ 1 tender joint, and at least 1 swollen knee or ankle joint at baseline

You may not qualify if:

• Contraindications for needle-arthroscopy such as joint replacement (in the affected knee or ankle joint).
• Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* synovial tissue * synovial tissue both obtained at timepoint 0 (before first ustekinumab injection) ,wk 12, and wk24 after starting treatment * peripheral blood obtained at wk 0, wk 4, 8, 12 and 24

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Dominique LP Baeten, MD PhD Prof

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique LP Baeten, MD PhD Prof

CONTACT

00312056; d.l.baeten@amc.uva.nl

Henriette MY de Jong, MD

CONTACT

00312056; h.m.dejong@amc.uva.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. D.L.P. Baeten

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: June 21, 2018
• Study Start: December 8, 2015
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

NL (1)