Juvenile Idiopathic ArthritisPhase 4MyJIANCT04614311
Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).
A Phase 4 study testing Triamcinolone Hexacetonide 20 MG/ML in people with Juvenile Idiopathic Arthritis, run by Oslo University Hospital at 5 sites in Norway.
Trial summary
Inhibitors of tumour necrosis factor (TNFa) reduce inflammation in patients with juvenile idiopathic arthritis (JIA), but only 20-40 percent achieve a state of no or very little disease activity. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Triamcinolone Hexacetonide 20 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 5 sitesNorway
- Study dates
- 1 Dec 2020to 6 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1-18 years of age at the time of signing the informed consent.
- Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA.
- Clinical indication for starting TNFi treatment according to consensus between at least two physicians.
- Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure).
- Juvenile Disease Activity Score (JADAS) >1 at baseline and at least one joint with active arthritis were joint injection is considered.
- Willing to give written consent (participant ≥ 16, guardians if < 16 years of age, both participants and guardians if 16-18) and comply with the requirements of the study protocol.
Who cannot join
- Medical Conditions
- Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
- Prior/Concomitant Therapy
- Used two or more TNFi.
- Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation.
- Other Exclusions
Show all 16Show fewer
- Known hypersensitivity to Triamcinolone hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol).
- Concomitant therapy with CYP3A-inhibitors or digitalis glycosides.
- Known inherited fructose intolerance
- Presence of hepatitis B surface antigen (HBsAg) at screening.
- Positive hepatitis C antibody test result at screening or within 12 months prior to starting study treatment.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (front), and TB testing. The choice of TB tests will be made by the investigator according to local licensing and standard of care.
- Having received live vaccines less than two weeks prior to randomisation.
- Drug / alcohol abuse which hampers adherence to the study protocol.
- Language barriers that hampers adherence to the study protocol.
- Pregnancy or breast-feeding.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Haukeland University Hospital
Bergen, 5021
Oslo University Hospital
Oslo, Oslo, 0424
Stavanger University Hospital
Stavanger
University Hospital of North Norway
Tromsø, 9019
St Olavs Hospital
Trondheim, Trønderlag
About this study
Official title: Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): the MyJIA Trial.
Inhibitors of tumour necrosis factor (TNFa) reduce inflammation in patients with juvenile idiopathic arthritis (JIA), but only 20-40 percent achieve a state of no or very little disease activity. Tailored glucocorticoid joint injections are widely used (usually in general anaesthesia), but no controlled studies have addressed the effect of this approach. In Norway there are unique possibilities for early interventions, rapid escalation of medication and individualised therapy. The investigators aim to find the optimal ways to increase disease control and improve quality of life for JIA patients.
The hypothesis is that JIA patients starting TNF-inhibitors with added steroid injection of inflamed joints, will lead to improved outcomes compared to TNF-inhibitors with no joint injections, and that therapeutic drug monitoring, modern imaging and biologic and clinical profiling can be utilised to characterise JIA patients with different anti-TNF responses.
Read more
MyJIA is a national investigator initiated 48 weeks RCT of JIA patients starting TNF-inhibitors; 202 JIA patients will be randomised at baseline to A) concomitant intra-articular glucocorticoid injections versus B) no injections. Primary endpoint is the rate of sustained remission from weeks 24 to 36. Possible risk factors for not reaching remission will be analysed including clinical characteristics, drug antibodies/serum concentrations, patients' reported health status and preferences, molecular signalling (based on transcriptional, cellular and genetic risk) and synovitis detected by modern imaging (ultrasound and whole-body MRI).
Patients will be recruited from all Norwegian health regions through an established collaboration. Unit of Paediatric Rheumatology, Oslo University Hospital, with an extensive research track in this field, will be the coordinating centre. Broad research cooperation across disciplines is established. The trial is highly innovative in evaluating treatment options and strategies to individualise and optimise the efficacy and safety of JIA treatment.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Triamcinolone Hexacetonide 20 MG/ML
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Hexacetonide 20 MG/MLDrug
Also called Lederspan
JIA patients (age 1-18 years) starting TNFi treatment randomised to intervention will receive treatment with intra articular glucocorticoids (triamcinolone hexacetonide) injections in inflamed joints
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intra-articular corticosteroid injections into active joints Receives: Drug: Triamcinolone Hexacetonide 20 MG/ML |
| Comparator | No intervention | No intra-articular injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of JIA participants with sustained inactive disease
The proportion of participants with sustained, inactive disease from week 24 to week 36.
Inactive disease is defined according the 2011 Wallace criteria:
- No active arthritis†
- Physician global assessment of disease activity score normal (0)
- Erythrocyte sedimentation rate (ESR) within normal range
- Morning stiffness ≤ 15 minutes
- No active uveitis
- No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA
In addition, no use of any i.a. or p.o. corticosteroids from week 20 to week 36.
†Active arthritis according to the ACR definition:
- a joint with swelling not due to bony enlargement OR, if no swelling is present
- limitation of motion accompanied by either pain on motion and/or tenderness.
Measured: Week 24 to week 36.
Secondary outcomes (6)
The proportion of participants with ACR pedi 30% response
American College of Rheumatology (ACR) paediatric 30% response (30% improvement in a minimum of 3 of any 6 variables in the paediatric core set criteria with no more than one of the remaining variables worsening more than 30%).
Pediatric core set criteria:
- Physician's global assessment of disease activity (visual analogue scale (VAS), range 0-100 where 0 represents best possible outcome).
- Patient's/parent's global assessment of overall well-being (VAS, range from 0-100 where 0 represents best possible outcome)
- Functional ability (Childhood Health Assessment Questionnaire, CHAQ, lower scores are indicative of better functioning)
- Number of joints with active arthritis (range 0-71 where 0 represents best possible outcome)
- Number of joints with limited range of movement (range 0-70 where 0 represents best possible outcome)
- Erythrocyte sedimentation rate (normalised to a 0-10 scale where 0 represents best possible outcome)
Measured: Baseline to week 6,12 and 24
The proportion of participants with ACR pedi 50,70 and 90% response
American College of Rheumatology (ACR) paediatric 50, 70 and 90% response (50,70 and 90% improvement in a minimum of 3 of any 6 variables in the pediatric core set (see above) criteria.
Measured: Baseline to week 6, 12 and 24.
Juvenile arthritis disease activity score (JADAS)
The JADAS is a composite measure of disease activity with a range from 0 to 101 where 0 represents the best possible outcome and 101 the worst possible outcome.
The JADAS is calculated as a sum of scores from:
- Physician's global assessment of disease activity (visual analogue scale ranging from 0-100 where 0 represents best possible outcome and and 100 the worst possible outcome).
- Patient's/parent's global assessment of overall well-being (visual analogue scale ranging from 0-100 where 0 represents best possible outcome and and 100 the worst possible outcome)
- Erythrocyte sedimentation rate (ESR) (normalized to a 0-10 scale, according to the following formula: (ESR (mm/hour)-20)/10. 0 represents best possible outcome and and 10 the worst possible outcome)
- Number of joints with active arthritis (range from 0 to 71 where 0 represents best possible outcome and and 71 the worst possible outcome)
Measured: Baseline to week 6, 12 and 24.
Time to inactive disease
Time (months) until participants reach inactive disease according to the Wallace criteria and JADAS.
Measured: Baseline to 48 weeks
Proportion of Participants with Minimal Disease Activity
Proportion of Participants with Minimal Disease Activity
Measured: Week 26 to 48
Change from baseline in arthritis-related pain severity as measured by pain VAS item
Change from Baseline in Arthritis-Related Pain Severity as Measured by Pain Visual Analog Scale (VAS).
The Pain VAS ranges from 0 to 100 where 0 represents no pain and 100 the worst possible level of pain.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Dec 2020
- Primary completion7 Nov 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel intervention were participants are assigned to either the control group or intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, Helse Stavanger HF
- Responsible party
- Principal investigator, Pernille Helen Bøyesen, Oslo University Hospital
- Investigators
- Pernille H Bøyesen, MD PhD, Study director, Oslo University HospitalAnna-Birgitte Aga, MD PhD, Principal investigator, Oslo University HospitalBerit Flatø, Prof, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614311
- Sponsor's protocol ID
- 171224
- Acronym
- MyJIA
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): the MyJIA Trial.
- ClinicalTrials.gov ID
- NCT04614311
- Acronym / sponsor ID
- MyJIA / 171224
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, Helse Stavanger HF
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhibitors of tumour necrosis factor (TNFa) reduce inflammation in patients with juvenile idiopathic arthritis (JIA), but only 20-40 percent achieve a state of no or very little disease activity. Tailored glucocorticoid joint injections are widely used (usually in general anaesthesia), but no controlled studies have addressed the effect of this approach. In Norway there are unique possibilities for early interventions, rapid escalation of medication and individualised therapy. The investigators aim to find the optimal ways to increase disease control and improve quality of life for JIA patients.
The hypothesis is that JIA patients starting TNF-inhibitors with added steroid injection of inflamed joints, will lead to improved outcomes compared to TNF-inhibitors with no joint injections, and that therapeutic drug monitoring, modern imaging and biologic and clinical profiling can be utilised to characterise JIA patients with different anti-TNF responses.
MyJIA is a national investigator initiated 48 weeks RCT of JIA patients starting TNF-inhibitors; 202 JIA patients will be randomised at baseline to A) concomitant intra-articular glucocorticoid injections versus B) no injections. Primary endpoint is the rate of sustained remission from weeks 24 to 36. Possible risk factors for not reaching remission will be analysed including clinical characteristics, drug antibodies/serum concentrations, patients' reported health status and preferences, molecular signalling (based on transcriptional, cellular and genetic risk) and synovitis detected by modern imaging (ultrasound and whole-body MRI).
Patients will be recruited from all Norwegian health regions through an established collaboration. Unit of Paediatric Rheumatology, Oslo University Hospital, with an extensive research track in this field, will be the coordinating centre. Broad research cooperation across disciplines is established. The trial is highly innovative in evaluating treatment options and strategies to individualise and optimise the efficacy and safety of JIA treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel intervention were participants are assigned to either the control group or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Triamcinolone Hexacetonide 20 MG/MLIntra-articular corticosteroid injections into active joints |
| Comparator | No intervention | –No intra-articular injections |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 1-18 years of age at the time of signing the informed consent.
- Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA.
- Clinical indication for starting TNFi treatment according to consensus between at least two physicians.
- Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure).
- Juvenile Disease Activity Score (JADAS) >1 at baseline and at least one joint with active arthritis were joint injection is considered.
Key exclusion criteria (16 listed)
- Medical Conditions
- Major comorbidity including uncontrolled infectious, neurological or mental disease, malignant disease, severe heart failure, severe renal failure, active ulcus ventriculi, and uncontrolled diabetes mellitus.
- Prior/Concomitant Therapy
- Used two or more TNFi.
- Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Hexacetonide 20 MG/MLAlso: LederspanJIA patients (age 1-18 years) starting TNFi treatment randomised to intervention will receive treatment with intra articular glucocorticoids (triamcinolone hexacetonide) injections in inflamed joints | Drug | Intervention |
Primary outcome
The proportion of JIA participants with sustained inactive disease
Time frame: Week 24 to week 36.
The proportion of participants with sustained, inactive disease from week 24 to week 36. Inactive disease is defined according the 2011 Wallace criteria: * No active arthritis† * Physician global assessment of disease activity score normal (0) * Erythrocyte sedimentation rate (ESR) within normal range * Morning stiffness ≤ 15 minutes * No active uveitis * No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA In addition, no use of any i.a. or p.o. corticosteroids from week 20 to week 36. †Active arthritis according to the ACR definition: 1. a joint with swelling not due to bony enlargement OR, if no swelling is present 2. limitation of motion accompanied by either pain on motion and/or tenderness.
6 secondary outcomes
The proportion of participants with ACR pedi 30% response
Time frame: Baseline to week 6,12 and 24
The proportion of participants with ACR pedi 50,70 and 90% response
Time frame: Baseline to week 6, 12 and 24.
Juvenile arthritis disease activity score (JADAS)
Time frame: Baseline to week 6, 12 and 24.
Time to inactive disease
Time frame: Baseline to 48 weeks
Proportion of Participants with Minimal Disease Activity
Time frame: Week 26 to 48
Change from baseline in arthritis-related pain severity as measured by pain VAS item
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille H Bøyesen, MD PhD study director
Oslo University Hospital
Anna-Birgitte Aga, MD PhD principal investigator
Oslo University Hospital
Berit Flatø, Prof principal investigator
Oslo University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Hexacetonide 20 MG/ML in people with Juvenile Idiopathic Arthritis, run by Oslo University Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of JIA participants with sustained inactive disease (time frame: Week 24 to week 36.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.