Juvenile Chronic PolyarthritisPhase 4NCT00443430
Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
A Phase 4 study testing methotrexate and methotrexate - etanercept - prednisolone arm in people with Juvenile Chronic Polyarthritis and Juvenile Idiopathic Arthritis, run by Seattle Children's Hospital at 15 sites in United States.
Trial summary
The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Chronic Polyarthritis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis
- What is being tested?
- methotrexate and methotrexate - etanercept - prednisolone arm
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2007to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
- Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
- Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
- Parent or guardian willing to provide informed consent
- Able to attend all study visits
Who cannot join
- Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:
- Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
- Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
- Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
- History of or active cancer of any type
- Active gastrointestinal disease (e.g., inflammatory bowel disease)
Show all 21Show fewer
- Chronic or acute kidney or liver disorder
- Significant blood clotting defect
- AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
- Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
- Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
- Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
- HIV infected
- Known past or current hepatitis infection
- Received a live virus vaccine within 1 month prior to baseline
- Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
- Pregnancy
- Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
- History of or current psychiatric illness that would interfere with study participation
- History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
- Inability to comply with study requirements for any reason
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Hospital of Boston
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Children's Hospital of Columbus
Columbus, Ohio, 43205
Texas Scottish Rite Hospital
Dallas, Texas, 75219
Duke University
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Schneider Children's Hospital
New Hyde Park, New York, 11040
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Stanford University Medical Center
Palo Alto, California, 94305
University of Utah
Salt Lake City, Utah, 84132
Rady Children's Hospital
San Diego, California, 92123-4282
University of California San Francisco Medical Center
San Francisco, California, 94143
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)
The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.
Read the detailed description
JIA is a type of arthritis with no definite cause and an onset prior to 16 years of age. JIA causes joint destruction, pain, and permanent disability. There are multiple types of JIA; collectively, they represent one of the most common chronic diseases in children and the most prevalent pediatric rheumatic illness. Poly-JIA, one type of JIA, affects at least five joints in the body within the first 6 months of disease. Long-term remission of poly-JIA is uncommon, and most children must remain on multiple combinations of medications for many years. The usual treatment for poly-JIA is based upon the gradual addition of medications that might be more effective in treating this disease. There is a need to find uniformly effective treatments for children with poly-JIA. Based on previous adult arthritis studies, there appears to be an early window of opportunity in the disease progression during which aggressive therapy has a profound beneficial long-term effect. The purpose of this study is to compare the effectiveness of two aggressive drug regimens in treating children with poly-JIA. Specifically, the study will determine whether aggressive therapy started in the first 6 months of disease onset can result in inactive disease and clinical remission while on these medications.
All participants will receive weekly methotrexate shots while in the study. In addition, participants will be randomly assigned to one of two groups:
- Group 1 participants will receive placebo etanercept shots for up to 12 months and daily placebo prednisolone liquid for 4 months.
- Group 2 participants will receive etanercept shots for up to 12 months and daily prednisolone liquid for 4 months.
The study will last up to 12 months and include two parts. Part A will last 1 to 6 months, depending on response to assigned treatments. If participants are still experiencing active arthritis at 6 months, they will be offered open-label treatment with etanercept and prednisolone. If participants experience inactive disease any time prior to 6 months, they will enter Part B of the study. During Part B, which will last up to 6 months, participants will remain on the same treatment regimen that they were provided in Part A. If participants experience inactive disease followed by a flare of disease any time during the study, they will stop participating.
During the study, there will be 11 study visits for all participants. Study visits will include a physical exam, including joint evaluations; blood and urine collection; and questionnaires regarding function, quality of life, medication compliance, other medications used, infections, and adverse symptoms.
Blood will be collected for translational studies.
- Conditions
- Juvenile Chronic Polyarthritis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis
- Being tested
- methotrexate, methotrexate - etanercept - prednisolone arm
- Keywords
- Childhood Arthritis, Juvenile Arthritis, Juvenile Arthritis Treatment, Childhood Arthritis Drug Treatment, Juvenile Arthritis Remission, Inactive Disease in Juvenile Arthritis, Childhood Polyarthritis, Extended Oligoarthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methotrexateDrug
Also called placebo enbrel, placebo prednisolone
Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone
methotrexate - etanercept - prednisolone armDrug
Also called enbrel, prednisone
methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate Arm | Active comparator | Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone Receives: Drug: methotrexate |
| Methotrexate-Etanercept-Prednisolone Arm | Active comparator | Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks Receives: Drug: methotrexate - etanercept - prednisolone arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Attain Inactive Disease by 6 Months
Measured: 6 months after initiation of study intervention
Secondary outcomes (2)
Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
Measured: Over 12 months maximum study participation per subject
Clinical Remission on Medication
6 months of clinical inactive disease
Measured: 12 months or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Juvenile Chronic PolyarthritisStudies of the same condition, open and under way.
- More trials run by Seattle Children's 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Amgen
- Responsible party
- Principal investigator, Carol Wallace, Seattle Children's Hospital
- Investigators
- Carol A. Wallace, MD, Principal investigator, Childrens Hospital and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443430
- Sponsor's protocol ID
- R01AR049762
- Other IDs
- 5R01AR049762-02
- Status last verified
- May 2013
- First submitted
- 2 Mar 2007
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885.
PubMed 16732547Wallace CA. Current management of juvenile idiopathic arthritis. Best Pract Res Clin Rheumatol. 2006 Apr;20(2):279-300. doi: 10.1016/j.berh.2005.11.008.
PubMed 16546057Wallace CA, Ruperto N, Giannini E; Childhood Arthritis and Rheumatology Research Alliance; Pediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol. 2004 Nov;31(11):2290-4.
PubMed 15517647Lim LSH, Lokku A, Pullenayegum E, Ringold S. Probability of Response in the First Sixteen Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials. Arthritis Care Res (Hoboken). 2023 Jun;75(6):1238-1249. doi: 10.1002/acr.25003. Epub 2023 Jan 18.
PubMed 36651601Jiang K, Wong L, Sawle AD, Frank MB, Chen Y, Wallace CA, Jarvis JN. Whole blood expression profiling from the TREAT trial: insights for the pathogenesis of polyarticular juvenile idiopathic arthritis. Arthritis Res Ther. 2016 Jul 7;18(1):157. doi: 10.1186/s13075-016-1059-1.
PubMed 27388672Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic DS, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance (CARRA). Clinically inactive disease in a cohort of children with new-onset polyarticular juvenile idiopathic arthritis treated with early aggressive therapy: time to achievement, total duration, and predictors. J Rheumatol. 2014 Jun;41(6):1163-70. doi: 10.3899/jrheum.131503. Epub 2014 May 1.
PubMed 24786928Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic D, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Hamilton S, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance. Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum. 2012 Jun;64(6):2012-21. doi: 10.1002/art.34343. Epub 2011 Dec 19.
PubMed 22183975
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)
- ClinicalTrials.gov ID
- NCT00443430
- Acronym / sponsor ID
- R01AR049762
- Conditions
- Juvenile Chronic Polyarthritis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis
- Keywords
- Childhood Arthritis, Juvenile Arthritis, Juvenile Arthritis Treatment, Childhood Arthritis Drug Treatment, Juvenile Arthritis Remission, Inactive Disease in Juvenile Arthritis, Childhood Polyarthritis, Extended Oligoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Amgen
- Study start
- May 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two aggressive drug regimens for children with poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.
Detailed description
JIA is a type of arthritis with no definite cause and an onset prior to 16 years of age. JIA causes joint destruction, pain, and permanent disability. There are multiple types of JIA; collectively, they represent one of the most common chronic diseases in children and the most prevalent pediatric rheumatic illness. Poly-JIA, one type of JIA, affects at least five joints in the body within the first 6 months of disease. Long-term remission of poly-JIA is uncommon, and most children must remain on multiple combinations of medications for many years. The usual treatment for poly-JIA is based upon the gradual addition of medications that might be more effective in treating this disease. There is a need to find uniformly effective treatments for children with poly-JIA. Based on previous adult arthritis studies, there appears to be an early window of opportunity in the disease progression during which aggressive therapy has a profound beneficial long-term effect. The purpose of this study is to compare the effectiveness of two aggressive drug regimens in treating children with poly-JIA. Specifically, the study will determine whether aggressive therapy started in the first 6 months of disease onset can result in inactive disease and clinical remission while on these medications.
All participants will receive weekly methotrexate shots while in the study. In addition, participants will be randomly assigned to one of two groups:
- Group 1 participants will receive placebo etanercept shots for up to 12 months and daily placebo prednisolone liquid for 4 months.
- Group 2 participants will receive etanercept shots for up to 12 months and daily prednisolone liquid for 4 months.
The study will last up to 12 months and include two parts. Part A will last 1 to 6 months, depending on response to assigned treatments. If participants are still experiencing active arthritis at 6 months, they will be offered open-label treatment with etanercept and prednisolone. If participants experience inactive disease any time prior to 6 months, they will enter Part B of the study. During Part B, which will last up to 6 months, participants will remain on the same treatment regimen that they were provided in Part A. If participants experience inactive disease followed by a flare of disease any time during the study, they will stop participating.
During the study, there will be 11 study visits for all participants. Study visits will include a physical exam, including joint evaluations; blood and urine collection; and questionnaires regarding function, quality of life, medication compliance, other medications used, infections, and adverse symptoms.
Blood will be collected for translational studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate Arm | Active comparator | Drug: methotrexateMethotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone |
| Methotrexate-Etanercept-Prednisolone Arm | Active comparator | Drug: methotrexate - etanercept - prednisolone armMethotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
- Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
- Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
- Parent or guardian willing to provide informed consent
- Able to attend all study visits
Key exclusion criteria (21 listed)
- Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:
- Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
- History of or active cancer of any type
- Active gastrointestinal disease (e.g., inflammatory bowel disease)
- Chronic or acute kidney or liver disorder
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 |
|---|---|---|
| methotrexateAlso: placebo enbrel, placebo prednisoloneMethotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone | Drug | Methotrexate Arm |
| methotrexate - etanercept - prednisolone armAlso: enbrel, prednisonemethotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks. | Drug | Methotrexate-Etanercept-Prednisolone Arm |
Primary outcome
Proportion of Participants Who Attain Inactive Disease by 6 Months
Time frame: 6 months after initiation of study intervention
2 secondary outcomes
Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
Time frame: Over 12 months maximum study participation per subject
Clinical Remission on Medication
Time frame: 12 months or end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16732547Lovell DJ, Reiff A, Jones OY, Schneider R, Nocton J, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Whitmore JB, White B, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006 Jun;54(6):1987-94. doi: 10.1002/art.21885.
- Background: PubMed 16546057Wallace CA. Current management of juvenile idiopathic arthritis. Best Pract Res Clin Rheumatol. 2006 Apr;20(2):279-300. doi: 10.1016/j.berh.2005.11.008.
- Background: PubMed 15517647Wallace CA, Ruperto N, Giannini E; Childhood Arthritis and Rheumatology Research Alliance; Pediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol. 2004 Nov;31(11):2290-4.
- Derived from this study: PubMed 36651601Lim LSH, Lokku A, Pullenayegum E, Ringold S. Probability of Response in the First Sixteen Weeks After Starting Biologics: An Analysis of Juvenile Idiopathic Arthritis Biologics Trials. Arthritis Care Res (Hoboken). 2023 Jun;75(6):1238-1249. doi: 10.1002/acr.25003. Epub 2023 Jan 18.
- Derived from this study: PubMed 27388672Jiang K, Wong L, Sawle AD, Frank MB, Chen Y, Wallace CA, Jarvis JN. Whole blood expression profiling from the TREAT trial: insights for the pathogenesis of polyarticular juvenile idiopathic arthritis. Arthritis Res Ther. 2016 Jul 7;18(1):157. doi: 10.1186/s13075-016-1059-1.
- Derived from this study: PubMed 24786928Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic DS, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance (CARRA). Clinically inactive disease in a cohort of children with new-onset polyarticular juvenile idiopathic arthritis treated with early aggressive therapy: time to achievement, total duration, and predictors. J Rheumatol. 2014 Jun;41(6):1163-70. doi: 10.3899/jrheum.131503. Epub 2014 May 1.
- Derived from this study: PubMed 22183975Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS, Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic D, Punaro MG, Chira P, Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Hamilton S, Johnson A, Huang B, Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance. Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum. 2012 Jun;64(6):2012-21. doi: 10.1002/art.34343. Epub 2011 Dec 19.
- Click here for the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Web siteLink provided by the sponsor.
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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.
Carol A. Wallace, MD principal investigator
Childrens Hospital and Regional Medical Center
15 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 methotrexate and methotrexate - etanercept - prednisolone arm in people with Juvenile Chronic Polyarthritis and Juvenile Idiopathic Arthritis, run by Seattle Children's Hospital at 15 sites in United States.
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 5 inclusion and 21 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Who Attain Inactive Disease by 6 Months (time frame: 6 months after initiation of study intervention). 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 NCT00443430, which also lists 7 linked publications.
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 31 May 2013.