An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04967950
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking Union Medical College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Secukinumab 300mg

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

Experimental: Secukinumab 150mg

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

Active Comparator: methotrexate

methotrexate

Interventions

Drug: - Secukinumab 300 MG

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.

Drug: - Secukinumab 150 MG

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.

Drug: - Methotrexate

methotrexate

Contact a Trial Team

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International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing, 100730

Site Contact

Xiaomei Leng

[email protected]

+8613681057089

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