Back to resultsAn Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
Primary Purpose
Psoriatic Arthritis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Secukinumab 300 MG
Secukinumab 150 MG
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility 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.
Sites / Locations
- Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Secukinumab 300mg
Secukinumab 150mg
methotrexate
Arm Description
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
methotrexate
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS)
Heel Entheses will be scored in terms of inflammatory and morphological components according to the RAMRIS and PsAMRIS composite semi-quantitative scale (0 to 3). The lowest HEMRIS score a participant can have at baseline is 0. The highest HEMRIS score expected at baseline will be 6, assuming that the heel entheses assessed shows a maximum of 3 points in inflammatory score, and a maximum of 3 points in structure damage.
Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis
Joints examined by the PsASon13 unilateral ultrasound composite score: Small finger joints: MCP2, MCP5, H-PIP1, H-PIP2, H-PIP3; Distal interphalangeal finger joints: H-DIP3; Small joints of feet: MTP1, MTP5, F-PIP1; Distal interphalangeal joints of feet: F-DIP2, F-DIP3; Large joints: wrist and knee. Lowest score a participant may have at baseline is 0. Highest score a participant may have at baseline is 184 (5 small finger joints, each ranging from 0 to 18; 1 distal interphalangeal finger joint, each ranging from 0 to 16; 3 small joints of feet, each ranging from 0 to 12; 2 distal interphalangeal joints of feet, each ranging from 0 to 12; 1 wrist ranging from 0 to 12; and 1 knee ranging from 0 to 6). Largest change expected from baseline to Week 16 is -118 points (improvement).
Proportion of patients achieving ACR20、ACR50 and ACR70 response.
The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP). ACR 20 response is achieved if ≥ 20%≥ 50%/≥ 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.
Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75)
Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 75 is at least a 90% improvement (reduction) in PASI score.
Change from Baseline in Dermatology Life Quality Index (DLQI) score
A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.
Change from Baseline in HAQ-DI score
Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Full Information
NCT ID
NCT04967950
First Posted
July 8, 2021
Last Updated
July 19, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04967950
Brief Title
An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
Official Title
An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Secukinumab 300mg
Arm Type
Experimental
Arm Description
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
Arm Title
Secukinumab 150mg
Arm Type
Experimental
Arm Description
Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
Arm Title
methotrexate
Arm Type
Active Comparator
Arm Description
methotrexate
Intervention Type
Drug
Intervention Name(s)
Secukinumab 300 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Secukinumab 150 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
methotrexate
Primary Outcome Measure Information:
Title
Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score
Description
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.
Time Frame
Baseline，Week 12 and Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS)
Description
Heel Entheses will be scored in terms of inflammatory and morphological components according to the RAMRIS and PsAMRIS composite semi-quantitative scale (0 to 3). The lowest HEMRIS score a participant can have at baseline is 0. The highest HEMRIS score expected at baseline will be 6, assuming that the heel entheses assessed shows a maximum of 3 points in inflammatory score, and a maximum of 3 points in structure damage.
Time Frame
Baseline and Week 24
Title
Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis
Description
Joints examined by the PsASon13 unilateral ultrasound composite score: Small finger joints: MCP2, MCP5, H-PIP1, H-PIP2, H-PIP3; Distal interphalangeal finger joints: H-DIP3; Small joints of feet: MTP1, MTP5, F-PIP1; Distal interphalangeal joints of feet: F-DIP2, F-DIP3; Large joints: wrist and knee. Lowest score a participant may have at baseline is 0. Highest score a participant may have at baseline is 184 (5 small finger joints, each ranging from 0 to 18; 1 distal interphalangeal finger joint, each ranging from 0 to 16; 3 small joints of feet, each ranging from 0 to 12; 2 distal interphalangeal joints of feet, each ranging from 0 to 12; 1 wrist ranging from 0 to 12; and 1 knee ranging from 0 to 6). Largest change expected from baseline to Week 16 is -118 points (improvement).
Time Frame
Baseline，Week 12 and Week 24
Title
Proportion of patients achieving ACR20、ACR50 and ACR70 response.
Description
The ACR is a standard criteria originally developed to measure the effectiveness of various arthritis medications or treatments in clinical trials for RA, but is also widely used in PsA. The ACR measures improvement in tender joint count (TJC) or swollen joint count (SJC), and improvement in at least 3 of the following 5 parameters: Patient Global Assessment (PtGA), Physician's Global Assessment of Disease Activity (PhGA), physical function (using HAQ-DI) and acute phase reactant (using CRP). ACR 20 response is achieved if ≥ 20%≥ 50%/≥ 70% improvement in tender joint count (TJC) or swollen joint count (SJC) as well as a ≥ 20%/≥ 50%/≥ 70% improvement in ≥ 3 of the other 5 parameters.
Time Frame
Baseline，Week 12 and Week 24
Title
Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75)
Description
Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 75 is at least a 90% improvement (reduction) in PASI score.
Time Frame
Baseline，Week 12 and Week 24
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) score
Description
A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.
Time Frame
Baseline and Week 24
Title
Change from Baseline in HAQ-DI score
Description
Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Leng, Dr.
Phone
+8613681057089
Email
lpumch@126.com
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Leng
Phone
+8613681057089
Email
lpumch@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
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