Trial · NCT04967950
An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
NCT04967950, Phase 1, Unknown, Peking Union Medical College Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients. Trials, record NCT04967950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04967950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
- NCT number
- NCT04967950
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Peking Union Medical College Hospital
- Conditions
- Psoriatic Arthritis
- Interventions
- Secukinumab 300 MG, Secukinumab 150 MG, Methotrexate
- First posted
- 2021-07-20
- Last updated
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score | Baseline，Week 12 and Week 24 | 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 | Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS) | Baseline and Week 24 | 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. |
| Secondary | Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis | Baseline，Week 12 and Week 24 | 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). |
| Secondary | Proportion of patients achieving ACR20、ACR50 and ACR70 response. | Baseline，Week 12 and Week 24 | 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. |
| Secondary | Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75) | Baseline，Week 12 and Week 24 | 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. |
| Secondary | Change from Baseline in Dermatology Life Quality Index (DLQI) score | Baseline and Week 24 | 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. |
| Secondary | Change from Baseline in HAQ-DI score | Baseline and Week 24 | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04967950
GET https://conductscience.org/api/trials/v1/NCT04967950/registered