An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

NCT04967950 | Unknown Phase 1

• 1 other identifier: PUMCH-IL17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of enthesitis in psoriatic arthritis patients. This study will be the first randomized trial of a biologic therapy in participants with psoriatic arthritis, using imaging test.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score

  Twelve entheses will be scored in terms of inflammatory and morphological components according to the OMERACT enthesitis composite semi-quantitative scale (0 to 3). The lowest OMERACT score a participant can have at baseline is 1 (based on Inclusion Criterion, which requires at least 1 points in the B-mode or the Doppler mode in at least one active enthesis ). The highest OMERACT score expected at baseline will be 136, assuming that each of the 12 entheses assessed shows a maximum of 3 points in the gray scale score, and a maximum of 3 points in the Doppler score.

  Baseline，Week 12 and Week 24

Secondary Outcomes (6)

• Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS)

  Baseline and Week 24

• Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis

  Baseline，Week 12 and Week 24

• Proportion of patients achieving ACR20、ACR50 and ACR70 response.

  Baseline，Week 12 and Week 24

• Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75)

  Baseline，Week 12 and Week 24

• Change from Baseline in Dermatology Life Quality Index (DLQI) score

  Baseline and Week 24

Study Arms (3)

Secukinumab 300mg

EXPERIMENTAL

Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw

Drug: Secukinumab 300 MG

Secukinumab 150mg

EXPERIMENTAL

Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw

Drug: Secukinumab 150 MG

methotrexate

ACTIVE COMPARATOR

methotrexate

Drug: Methotrexate

Interventions

Secukinumab 300 MG DRUG

Secukinumab 150 mg s.c. with loading dose at baseline, week 1,2,3,4 and then every 4 weeks from week 5 up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, Secukinumab 150 mg will be with a switch to 300 mg.

Secukinumab 300mg

Secukinumab 150 MG DRUG

Methotrexate 15 mg po. every week up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, methotrexate with a switch to Secukinumab 150 mg at 12 weeks.

Secukinumab 150mg

Methotrexate DRUG

methotrexate

methotrexate

Eligibility Criteria

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

You may qualify if:

• aged 18 years or older,;
• had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
• had at least 1 active enthesitis (confirmed by ultrasound) ;
• had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
• had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.

You may not qualify if:

• History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
• Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
• Peripheral neuropathy;
• Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
• recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) \>3x upper limit of normal (ULN) at screening; estimated creatinine clearance \<40 mL/min.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab; Methotrexate

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)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaomei Leng, Dr.

CONTACT

+8613681057089; lpumch@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: July 15, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-06

Locations

CN (1)