Trial · NCT04804553
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
NCT04804553, Phase 3, Recruiting, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis. Trials, record NCT04804553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04804553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
- NCT number
- NCT04804553
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Amgen
- Conditions
- Active Juvenile Psoriatic Arthritis
- Interventions
- Apremilast, Placebo
- First posted
- 2021-03-18
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16 | Baseline to Week 16 | The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>30 percent. The ACR Pedi consists of 6 core criteria: 1. physician global assessment (PGA) of disease activity (visual analog scale \[VAS\]) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the Childhood Health Assessment Questionnaire \[CHAQ\]); 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (C-reactive protein \[CRP\]). |
| Secondary | Change from Baseline in Participants Assessment of Pain at Week 16 | Baseline to Week 16 | The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain". |
| Secondary | Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16 | Baseline to Week 16 | The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by \>20 percent, \>50 percent, \>70 percent or \>90 percent respectively. The ACR Pedi consists of 6 core criteria: 1. PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity 2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being 3. functional ability (assessed using the CHAQ) 4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6\. laboratory marker of inflammation (CRP). |
| Secondary | Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16 | Baseline to Week 16 | PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity. |
| Secondary | Change from Baseline in the Assessment of Overall Well-being at Week 16 | Baseline to Week 16 | Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver. |
| Secondary | Change from Baseline in the Number of Joints with Active Arthritis at Week 16 | Baseline to Week 16 | Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both. |
| Secondary | Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16 | Baseline to Week 16 | |
| Secondary | Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16 | Baseline to Week 16 | |
| Secondary | Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16 | Baseline to Week 16 | The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life. The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ. |
| Secondary | Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16 | Baseline to Week 16 | JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein \[CRP\]). There are 4 components of the JADAS: 1. Active joint count (71 joints) 2. PGA (0 to 100) measured on a VAS 3. Patient/parent global assessment of well-being (0 to 100) measured on a VAS 4. CRP (normalized to a 0 to 10 scale) The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles . The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
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/NCT04804553
GET https://conductscience.org/api/trials/v1/NCT04804553/registered