A Long-Term, Open-Label, Study for Treatment of JIA

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004915-22-DE

Enrollment

340

Registered

2012-06-11

Start date

2012-09-17

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

JUVENILE IDIOPATHIC ARTHRITIS (JIA) MedDRA version: 23.1 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: XELJANZ Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 1. JIA subjects aged 2 to 40 kg; Or as according to local standards. 8. If receiving sulfasalazine, chloroquine, or hydroxychloroquine treatment, administer according to local standards. 9. Evidence of a personally signed/dated ICD with assent as appropriate indicating that the subject (or a legally acceptable representative/parent(s)/legal guardian) has been informed of all aspects of the study. 10. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. 11. Subjects for whom, in the Investigator's opinion, treatment with tofacitinib is considered clinically appropriate. Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet the below: 12. No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as defined in the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 340 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study: 1. Blood dyscrasias, including: Hgb 1 episode) herpes zoster or a single episode of disseminated herpes zoster or a single episode of disseminated (both oral and genital lesions simultaneously, or widespread lesions not contained to oral or genital regions alone) herpes simplex. 11. Taking potent and moderate CYP3A4 inhibitors. 12. Taking potent and moderate CYP3A4 inducers. 13. Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug. 14. Any prior treatment with non B cell specific lymphocyte depleting agents/therapies. 15. Pregnant or nursing females. 16. IM or IV corticosteroids in the 4 weeks prior to first dose of study drug. 17. Vaccination with live or attenuated vaccines within 6 weeks prior to first dose of study drug. 18. Use of prohibited prescription/nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to first dose of study drug. 19. Herbal supplements must be discontinued at least 4 weeks prior to first dose of study drug. 20. First degree relative with a hereditary immunodeficiency; IgA deficiency not exclusionary. 21. Malignancy or history of malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 22. Recent (within 28 days prior to first dose of study drug) significant trauma or major surgery. 23. Unwilling/unable to comply with the Lifestyle Guidelines in the protocol. 24. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality. 25. Child of or related to investigational site staff members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study. 26. Any factors or clinical characteristics potentially related to the risk of VTE that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results. 27. History of allergies, intolerance or hypersensitivity to lactose or tofacitinib, or any other excipients of the IMP.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.;Secondary Objective: The secondary objective of this study is to evaluate the persistence of efficacy of tofacitinib for treatment of the signs and symptoms of JIA.;Primary end point(s): Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will be collected to assess growth and physical development.;Timepoint(s) of evaluation of this end point: Primary end points consist of 4 items: 1) Standard Lab Safety Data 2) AE assessment 3) body weight and height 4) Tanner Stage Standard Lab Safety Data is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 lab is collected at 6 month intervals. AE assessment is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 AE assessment is completed at 6 month intervals. Body weight and height is recorded at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 body weight and height is collected at 6 month intervals. Tanner stage is assessed at Baseline and annually thereafter.	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.;Secondary Objective: The secondary objective of this study is to evaluate the persistence of efficacy of tofacitinib for treatment of the signs and symptoms of JIA.;Primary end point(s): Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will be collected to assess growth and physical development.;Timepoint(s) of evaluation of this end point: Primary end points consist of 4 items: 1) Standard Lab Safety Data 2) AE assessment 3) body weight and height 4) Tanner Stage Standard Lab Safety Data is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 lab is collected at 6 month intervals. AE assessment is performed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 AE assessment is completed at 6 month intervals. Body weight and height is recorded at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 body weight and height is collected at 6 month intervals. Tanner stage is assessed at Baseline and annually thereafter.

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Secondary

Measure	Time frame
Secondary end point(s): The following efficacy parameters will be assessed: • Physician global evaluation of disease activity at each visit. • Number of joints with active arthritis at each visit. • Number of joints with limitation of motion at each visit. • Index of inflammation (C reactive protein [CRP]) and Erythrocyte Sedimentation Rate [ESR]) at each visit. • Childhood Health Assessment Questionnaire (CHAQ) at each visit. • Parent's Assessment of Physical Function (CHAQ Disability Index). • Parent's Assessment of Child's Arthritis Pain (CHAQ Discomfort Index, Visual Analog Scale [VAS]). • Parent's Assessment of Overall Wellbeing (CHAQ subsection Visual Analog Scale [VAS]). • JIA American College of Rheumatology (ACR) response at each visit and occurrence of JIA ACR disease flare after Month 3. • JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. • Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27-CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit. •Eligibility of tapering defined per protocol for corticosteroids, MTX/lefluomide, and tofacitinib. •In subjects with sJIA: “Absence of Fever”, defined as absence of fever due to sJIA in the week preceding the assessment at each visit. • In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain response at various visits. • In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits. ;Timepoint(s) of evaluation of this end point: The Secondary endpoints (section 2.2.2) will be assessed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 the assessments will be completed at 6 month intervals.	—

Measure

Time frame

Secondary end point(s): The following efficacy parameters will be assessed: • Physician global evaluation of disease activity at each visit. • Number of joints with active arthritis at each visit. • Number of joints with limitation of motion at each visit. • Index of inflammation (C reactive protein [CRP]) and Erythrocyte Sedimentation Rate [ESR]) at each visit. • Childhood Health Assessment Questionnaire (CHAQ) at each visit. • Parent's Assessment of Physical Function (CHAQ Disability Index). • Parent's Assessment of Child's Arthritis Pain (CHAQ Discomfort Index, Visual Analog Scale [VAS]). • Parent's Assessment of Overall Wellbeing (CHAQ subsection Visual Analog Scale [VAS]). • JIA American College of Rheumatology (ACR) response at each visit and occurrence of JIA ACR disease flare after Month 3. • JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. • Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27-CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit. •Eligibility of tapering defined per protocol for corticosteroids, MTX/lefluomide, and tofacitinib. •In subjects with sJIA: “Absence of Fever”, defined as absence of fever due to sJIA in the week preceding the assessment at each visit. • In subjects with Enthesitis Related Arthritis (ERA): Change from baseline in the Tender Entheseal Assessment, Modified Schober's Test, Overall Back Pain and Nocturnal Back Pain response at various visits. • In subjects with psoriatic arthritis (PsA): Change from baseline in body surface area (BSA) affected by psoriasis and Physician's Global Assessment (PGA) of psoriasis) at various visits. ;Timepoint(s) of evaluation of this end point: The Secondary endpoints (section 2.2.2) will be assessed at Baseline, and Months 1, 3, 6, 9, and 12. During study years 2 - 10 the assessments will be completed at 6 month intervals.

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Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Costa Rica, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Trials.gov Call Center

Pfizer Inc.

clinicaltrials.govcallcenter@pfizer.com0018007181021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026