Recruiting

Personalized Medicine

Sponsor:

The Hospital for Sick Children

Code:

NCT06560606

Conditions

Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Childhood arthritis is a chronic disabling disease. New medications called biologic therapies are now available to treat arthritis that target key biologic molecules that cause inflammation. Biologic therapies, while very effective in treating arthritis in children, may have serious side effects including infections and potentially cancers, and are very expensive and doctors don't know, which one to choose for which child. The investigators will develop tests that enable them to learn about the biology of each child's arthritis and be able to predict when and which biologic therapy to start and when to stop.

Conditions

Juvenile Idiopathic Arthritis

Study ID

NCT06560606

Start date

Aug 24, 2018

Status verified date

Aug, 2024

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

Cohort 1: - Biologic Basis of JIA

  • ≤18 years\*
  • Active objective arthritis suspected to be JIA or diagnosed with JIA within 6 months of enrolment
  • Treatment naïve except for NSAIDs, allowed to have received NSAIDS within 6 months of diagnosis

Cohort 2 - Start Biologics

  • JIA diagnosis as per ILAR criteria (all subtypes)
  • ≤18 years\*
  • Active arthritis
  • For sJIA, active disease not necessarily with arthritis.
  • Time of start, restart or switch biologic therapy: e.g. failure, insufficient/partial response or intolerance

Cohort 3 - Stop Biologics

  • JIA diagnosis as per ILAR criteria (all subtypes)
  • ≤18 years\*
  • Inactive disease
  • Discontinuing/tapering biologics for inactive disease

Cohort 4: Extreme Phenotypes

  • Unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations
  • High suspicion of genetic contribution
  • Severely affected patients with difficult to control disease (ie failure of multiple biologics)

Exclusion Criteria:

Cohort 1 :

  • Arthritis explained by another diagnosis
  • Joint injections as previous treatment less than 4 weeks prior to enrollment

Cohort 2:

  • Arthritis explained by any other cause
  • Start on biologics as an indication for uveitis only

Cohort 3:

- Tapering scheme > 12 months to complete biologics stop

Cohort 4:

- Arthritis explained by another diagnosis

Study Design

Enrollment

4100 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1 - Biologic Basis of JIA

The objectives for this group are to help researchers look at childhood arthritis and determine which management approach is best for each individual child.

To be eligible for this group:

Participant must be ≤ 18 years of age at time of study enrollment. Participant is suspected to have JIA. Participant has not received any treatment other than non-steroidal anti-inflammatory drugs, such as acetaminophen.

Cohort 2 - Start Biologics

The objectives for this group are to help researchers develop a tool to predict response to therapy.

To be eligible for this group:

Participant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is active. Participant will be starting, re-starting or switching to a new biologic therapy.

Cohort 3 - Stop Biologics

The objectives for this group are to help researchers develop a tool to predict who will remain in remission after discontinuing therapy.

To be eligible for this group:

Participant ≤ 18 years of age at time of study enrollment. Participant has been diagnosed with JIA and arthritis is inactive. Participant will be stopping or tapering biologic therapy.

Cohort 4: Extreme Phenotypes

The objective for this group is new gene discovery and drug target identification.

To be eligible for this group:

There is high suspicion of genetic contribution. Participants are severely affected with difficult to control arthritis or systemic disease.

There is unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations

Primary outcome measure

  • Prospectively collect essential clinical data elements from children with new onset JIA [ Time Frame: Up to 24 months ]
  • Evaluate clinical outcomes associated with the use of therapeutic agents in children with JIA [ Time Frame: Up to 24 months ]
  • Evaluate clinical outcomes associated with the de-prescribing of therapeutic agents in children with JIA [ Time Frame: Up to 24 months ]
  • Prospectively collect essential clinical data elements from children with extreme phenotypes of JIA. [ Time Frame: Up to 12 months ]
  • Prospectively collect essential biological data elements from children with new onset JIA [ Time Frame: Up to 24 months ]
  • Evaluate biological outcomes associated with the use of therapeutic agents in children with JIA [ Time Frame: Up to 24 months ]
  • Evaluate biological outcomes associated with the de-prescribing of therapeutic agents in children with JIA [ Time Frame: Up to 24 months ]
  • Prospectively collect essential biological data elements from children with extreme phenotypes of JIA [ Time Frame: Up to 12 months ]
  • Prospectively collect essential socioeconomic data elements from children with new onset JIA [ Time Frame: Up to 12 months ]
  • Evaluate the socioeconomic impact associated with the use of therapeutic agents in children with JIA [ Time Frame: Up to 12 months ]
  • Evaluate the socioeconomic impact associated with the de-prescribing of therapeutic agents in children with JIA [ Time Frame: Up to 24 months ]
  • Prospectively collect essential socioeconomic data elements from children with extreme phenotypes of JIA [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Alexander Mosoiu

416-813-7654alexander.mosiu@sickkids.ca

Amy Xu

416-813-7654amy.xu@sickkids.ca

Locations

Alberta Children's Hospital - University of Calgary

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Principal Investigator:

Paivi Miettunen, MD

Stollery Children's Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Principal Investigator:

Dax G Rumsey, MD, MSc, FRCP(C)

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Principal Investigator:

Lori Tucker, MD, FRCPC

Children's Hospital Health Science Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Principal Investigator:

Lily Lim, MBBS, MRCPCH, FRCPC, PhD

Janeway Children's Hospital and Rehabilitation Centre

Recruiting

St John's, Newfoundland and Labrador, Canada, A1B 3V6

Principal Investigator:

Paul Dancey, MD, FRCPC

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Principal Investigator:

Adam Huber, MD

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Principal Investigator:

Michelle Batthish, MD

Children's Hospital, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Principal Investigator:

Roberta Berard, MD

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Michele Gibbon

mgibbon@cheo.on.ca

Principal Investigator:

Ciaran Duffy, MB

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Principal Investigator:

Shirley Tse, MD

Montréal Children's Hospital

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Principal Investigator:

Claire LeBlanc, M.A, MD, FRCPC, Dip Sport Med

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 5A2

Principal Investigator:

Alan Rosenberg

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2024-08-19.