Mechanism of Action of Anti-IL17 Therapy in Peripheral Spondyloarthritis

NCT03358134 | Completed Phase 3

• 2 other identifiers: AMC__45246_MoA_aIL172013-002709-79
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the mechanism of action on target tissue level of anti Interleukine-17 (anti-IL-17) an therapy in peripheral spondyloarthritis. Patients will be treated with anti-IL-17 therapy (secukinumab) for 12 weeks and with a 2 year extension period thereafter. At week 0 and 12 peripheral blood, synovial tissue and skin will be analysed with different techniques, including immunohistochemistry, RNA analysis and tissue culture to assess the effect of the therapy on inflammatory pathways.

Conditions

Spondylarthropathies

Keywords

Peripheral Spondylarthropathies; Psoriatic arthritis; Reactive arthritis

Outcome Measures

Primary Outcomes (2)

• Biological changes induced by therapy on target tissue (synovium)

  Molecular changes of the synovium as measured by expression of several cytokines/chemokines by quantitative polymerase chain reaction (qPCR) as measured by a change in cytokine expression between baseline and week 12.

  week 0 and week 12

• Changes of cellular infiltrate in the target tissue (synovium)

  Changes in cell count measured by immunohistochemistry (on a 0-4 semi-quantitative analysis scale)

  week 0 and week 12

Secondary Outcomes (2)

• Adverse events

  between day0 and 2 yrs of treatment

• Vessel wall inflammation

  week 0 and week 12

Study Arms (1)

Secukinumab

EXPERIMENTAL

All patients will be treated with active treatment. (anti-IL17)

Drug: Secukinumab

Interventions

Secukinumab DRUG

anti IL17 therapy (subcutaneous)

Also known as: AIN457

Secukinumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant/non-lactating females age 18-70
• Diagnosis of SpA according to ESSG criteria and/or ASAS criteria
• 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:

• Evidence for infectious or malignant process (on chest X ray/MRI etc)
• Patients taking opioid analgetics
• Previous IL-17 therapy exposure
• Previous use of cell-depleting therapies, biological immunomodulators (except for TNF blockade , as 25% may have been previously treated with 1 TNF blocking agent)
• Significant medical problems or diseases

Sponsors & Collaborators

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

Study Sites (1)

Academic Medical Center Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Spondylarthropathies; Arthritis, Psoriatic; Arthritis, Reactive

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arthritis, Infectious; Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• dominique LP Baeten, MD PhD prof.

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: November 30, 2017
• Study Start: March 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

NL (1)