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Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA). (MyJIA)

Primary Purpose

Juvenile Idiopathic Arthritis

Status

Recruiting

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Triamcinolone Hexacetonide 20 MG/ML

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Sites / Locations

St Olavs HospitalRecruiting
Haukeland University HospitalRecruiting
Oslo University HospitalRecruiting
Stavanger University HospitalRecruiting
University Hospital of North NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Comparator

Arm Description

Intra-articular corticosteroid injections into active joints

No intra-articular injections

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

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)

Time to inactive disease

Time (months) until participants reach inactive disease according to the Wallace criteria and JADAS.

Proportion of Participants with Minimal Disease Activity

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.

Full Information

NCT ID

NCT04614311

First Posted

October 28, 2020

Last Updated

September 27, 2022

Sponsor

Oslo University Hospital

Collaborators

The Research Council of Norway, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, Helse Stavanger HF

1. Study Identification

Unique Protocol Identification Number

NCT04614311

Brief Title

Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).

Acronym

MyJIA

Official Title

Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA): The MyJIA Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

August 16, 2023 (Anticipated)

Study Completion Date

November 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

The Research Council of Norway, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, Helse Stavanger HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Parallel intervention were participants are assigned to either the control group or intervention group.

Masking

Outcomes Assessor

Masking Description

The individual who evaluates joints clinically will be blinded to study information.

Allocation

Randomized

Enrollment

202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Intra-articular corticosteroid injections into active joints

Arm Title

Comparator

Arm Type

No Intervention

Arm Description

No intra-articular injections

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Hexacetonide 20 MG/ML

Other Intervention Name(s)

Lederspan

Intervention Description

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

Primary Outcome Measure Information:

Title

The proportion of JIA participants with sustained inactive disease

Description

Time Frame

Week 24 to week 36.

Secondary Outcome Measure Information:

Title

The proportion of participants with ACR pedi 30% response

Description

Time Frame

Baseline to week 6,12 and 24

Title

The proportion of participants with ACR pedi 50,70 and 90% response

Description

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.

Time Frame

Baseline to week 6, 12 and 24.

Title

Juvenile arthritis disease activity score (JADAS)

Description

Time Frame

Baseline to week 6, 12 and 24.

Title

Time to inactive disease

Description

Time (months) until participants reach inactive disease according to the Wallace criteria and JADAS.

Time Frame

Baseline to 48 weeks

Title

Proportion of Participants with Minimal Disease Activity

Description

Proportion of Participants with Minimal Disease Activity

Time Frame

Week 26 to 48

Title

Change from baseline in arthritis-related pain severity as measured by pain VAS item

Description

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Berit Flatø, Prof

Phone

004723070000

berit.flato@medisin.uio.no

First Name & Middle Initial & Last Name or Official Title & Degree

Pernille Bøyesen, MD PhD

Phone

004795780514

pernilleboyesen@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pernille H Bøyesen, MD PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anna-Birgitte Aga, MD PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Berit Flatø, Prof

Organizational Affiliation

Oslo University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

St Olavs Hospital

City

Trondheim

State/Province

Trønderlag

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marite Rygg, Prof

Phone

004772 57 30 00

marite.rygg@ntnu.no

Facility Name

Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karin B Tylleskär, MD

Phone

00 47 55 97 50 00

karin.tylleskar@helse-bergen.no

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pernille Bøyesen, MD PhD

Phone

004791502770

pernilleboyesen@gmail.com

First Name & Middle Initial & Last Name & Degree

Anna_Birgitte Aga, MD PhD

Phone

004791502770

anna.birgitte.aga@gmail.com

Facility Name

Stavanger University Hospital

City

Stavanger

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bjørn Barstad, MD PhD

Phone

+4751518000

bjorn.barstad@sus.no

Facility Name

University Hospital of North Norway

City

Tromsø

ZIP/Postal Code

9019

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ellen B Nordal, Ass Prof

Phone

00 47 776 26000

Ellen.Berit.Nordal@unn.no

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Strategies Towards Personalised Treatment in Juvenile Idiopathic Arthritis (JIA).

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