Juvenile SpondyloarthritisPhase 4BACK-OFF JSpANCT04891640
Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis
A Phase 4 study testing Standard TNFi Therapy, TNFi fixed longer dosing intervals and Stop TNFi treatment in people with Juvenile Spondyloarthritis, run by Children's Hospital of Philadelphia at 31 sites in 2 countries.
Trial summary
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 31 participating pediatric healthcare systems. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Juvenile Spondyloarthritis
- What is being tested?
- Standard TNFi Therapy, TNFi fixed longer dosing intervals and Stop TNFi treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 11 Nov 2021to 1 Jun 2026
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females age 8 to 21 years
- Juvenile SpA diagnosis:
- Symptom onset before their 16th birthday:
- o International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis enthesitis-related arthritis subtype
- OR;
- Symptom onset before their 18th birthday:
Show all 16Show fewer
- o Pediatric Rheumatology International Trials Organization (PRINTO) revision of the ILAR criteria enthesitis spondylitis-related JIA
- Peripheral arthritis and enthesitis, or
- Arthritis or enthesitis, plus ≥3 months of inflammatory back pain and sacroiliitis on imaging, or
- Arthritis or enthesitis plus 2 of the following: (1) sacroiliac joint tenderness; (2) inflammatory back pain; (3) presence of HLA-B27 antigen; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative.
- If peripheral arthritis is present, it should persist for at least 6 weeks.
- Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or TNFi biosimilar) at standard doses
- Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
- English speaking or Spanish speaking
- Subject's treating physician recommended that he/she is a good candidate to participate in the study, which may include a modified therapy
- Interested and willing to de-escalate TNFi therapy
Who cannot join
- 1) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
Akron Children's Hospital
Akron, Ohio, 44302
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Children's Hospital of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55455
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Hospital for Special Surgery
New York, New York, 10021
Nemours Children's Health
Orlando, Florida, 32827
Stanford University
Palo Alto, California, 94304
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's
Phoenix, Arizona, 85006
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
Cohen Children's Medical Center
Queens, New York, 11040
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Health System
Washington D.C., District of Columbia, 20010
Nemours Children's Hospital
Wilmington, Delaware, 19803
About this study
Official title: Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 31 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.
Read the detailed description
This project is a prospective, 12-month (+/- 1 month) pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months (+/- 1 month) through the study endpoint at 12 months (+/- 1 month). After subjects have followed their treatment assignment for 12 months (+/- 1 month), those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.
- Conditions
- Juvenile Spondyloarthritis
- Being tested
- Standard TNFi Therapy, TNFi fixed longer dosing intervals, Stop TNFi treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TNFi TherapyOther
Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.
TNFi fixed longer dosing intervalsOther
Participants randomly assigned to this arm will increase the time between TNFi medication doses.
- Adalimumab- from every 2 to 3 weeks
- Certolizumab- from every 2 to 4 weeks
- Etanercept- from every 1 to 2 weeks
- Golimumab- from every 4 to 6 weeks
- Infliximab- from baseline to baseline + 2 weeks
Stop TNFi treatmentOther
Participants randomly assigned to this arm will stop TNFi medication.
| Study group | Role | What they receive |
|---|---|---|
| TNFi Standard Therapy | Active comparator | Continue fixed standard treatment (i.e., no change from current therapy) Receives: Other: Standard TNFi Therapy |
| TNFi fixed longer dosing intervals | Experimental | Fixed longer dosing intervals of TNFi (i.e., increased time between doses) Receives: Other: TNFi fixed longer dosing intervals |
| TNFi Therapy Withdrawal | Experimental | Stop TNFi treatment Receives: Other: Stop TNFi treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Juvenile Spondyloarthritis (JSpA) flare
JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as ≥3 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.
Measured: 12 months
Secondary outcomes (1)
Pain interference (as measured by the PROMIS short form)
Pain interference (as measured by the PROMIS short form) of children with spondyloarthritis in the three treatment arms. The PROMIS short form is a validated questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life.The PROMIS short form includes 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation equal to 10.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start11 Nov 2021
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891640
- Sponsor's protocol ID
- 21-018442
- Other IDs
- : GRT-00001036
- Acronym
- BACK-OFF JSpA
- Status last verified
- Sep 2026
- First submitted
- 14 May 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weiss PF, Sears CE, Brandon TG, Forrest CB, Neu E, Kohlheim M, Leal J, Xiao R, Lovell D. Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA): study protocol for a randomized pragmatic trial. Trials. 2023 Feb 8;24(1):100. doi: 10.1186/s13063-022-07038-6.
PubMed 36755328
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
- ClinicalTrials.gov ID
- NCT04891640
- Acronym / sponsor ID
- BACK-OFF JSpA / 21-018442
- Conditions
- Juvenile Spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 May 2021 (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.
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 31 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.
Detailed description
This project is a prospective, 12-month (+/- 1 month) pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months (+/- 1 month) through the study endpoint at 12 months (+/- 1 month). After subjects have followed their treatment assignment for 12 months (+/- 1 month), those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNFi Standard Therapy | Active comparator | Other: Standard TNFi TherapyContinue fixed standard treatment (i.e., no change from current therapy) |
| TNFi fixed longer dosing intervals | Experimental | Other: TNFi fixed longer dosing intervalsFixed longer dosing intervals of TNFi (i.e., increased time between doses) |
| TNFi Therapy Withdrawal | Experimental | Other: Stop TNFi treatmentStop TNFi treatment |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Males or females age 8 to 21 years
- Juvenile SpA diagnosis:
- o International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis enthesitis-related arthritis subtype
- OR;
- o Pediatric Rheumatology International Trials Organization (PRINTO) revision of the ILAR criteria enthesitis spondylitis-related JIA
Key exclusion criteria (1 listed)
- 1) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
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 |
|---|---|---|
| Standard TNFi TherapyParticipants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed. | Other | TNFi Standard Therapy |
| TNFi fixed longer dosing intervalsParticipants randomly assigned to this arm will increase the time between TNFi medication doses. * Adalimumab- from every 2 to 3 weeks * Certolizumab- from every 2 to 4 weeks * Etanercept- from every 1 to 2 weeks * Golimumab- from every 4 to 6 weeks * Infliximab- from baseline to baseline + 2 weeks | Other | TNFi fixed longer dosing intervals |
| Stop TNFi treatmentParticipants randomly assigned to this arm will stop TNFi medication. | Other | TNFi Therapy Withdrawal |
Primary outcome
Juvenile Spondyloarthritis (JSpA) flare
Time frame: 12 months
JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as ≥3 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.
1 secondary outcome
Pain interference (as measured by the PROMIS short form)
Time frame: 12 months
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 25 Sep 2026.
- Derived from this study: PubMed 36755328Weiss PF, Sears CE, Brandon TG, Forrest CB, Neu E, Kohlheim M, Leal J, Xiao R, Lovell D. Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA): study protocol for a randomized pragmatic trial. Trials. 2023 Feb 8;24(1):100. doi: 10.1186/s13063-022-07038-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard TNFi Therapy, TNFi fixed longer dosing intervals and Stop TNFi treatment in people with Juvenile Spondyloarthritis, run by Children's Hospital of Philadelphia at 31 sites in 2 countries.
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 16 inclusion and 1 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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?
Juvenile Spondyloarthritis (JSpA) flare (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891640, which also lists 1 linked publication.
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 25 Sep 2026.