Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
ConditionActive Juvenile Psoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorAmgen
About this trial
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female participants 5 to < 18 years of age at the time of randomization.
Arthritis and psoriasis, OR
Dactylitis
Nail pitting or onycholysis
Disqualifiers
Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
Presence of systemic juvenile idiopathic arthritis (JIA).
Trial design
Design model
Parallel
Treatments tested in this trial
Apremilast
DrugParticipants will receive apremilast orally.
Placebo
DrugParticipants will receive the matching placebo orally.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ApremilastExperimental treatment 1 intervention
Group B: Placebo to ApremilastPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at 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 \[CRP\]).
Time frame
Baseline to Week 16Secondary outcomes
1
Change from Baseline in Participants Assessment of Pain at 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".
Time frame
Baseline to Week 162
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at 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).
Time frame
Baseline to Week 163
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at 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.
Time frame
Baseline to Week 164
Change from Baseline in the Assessment of Overall Well-being at 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.
Time frame
Baseline to Week 16 Source ClinicalTrials.gov