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Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01500551
First received: December 22, 2011
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: Tofacitinib
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label Follow-Up Study Of Tofacitinib For Treatment Of Juvenile Idiopathic Arthritis (JIA)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development. [ Time Frame: up to 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physician global evaluation of disease activity at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Number of joints with active arthritis at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Number of joints with limitation of motion at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Index of inflammation (C‑reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Parent's Assessment of Child's Arthritis Pain (Childhood Health Assessment Questionnaire [CHAQ] Discomfort Index, Visual Analog Scale [VAS])at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • Parent's Global Assessment of Overall Wellbeing (Childhood Health Assessment Questionnaire [CHAQ] subsection, Visual Analog Scale [VAS])at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • 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 responses at various visits. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 290
Study Start Date: March 2013
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tofacitinib
All patients will be in tofacitinib treatment group.
Drug: Tofacitinib

Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight.

Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 ‑ < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml)

Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution.

Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing.

Other Name: CP 690,550, Xeljanz
Drug: Tofacitinib
For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.
Other Name: CP-690,550, Xeljanz

Detailed Description:

This is a Phase 2/3, long term, open‑label, follow‑up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.

Approximately 290 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.

This study (A3921145) is planned to run until the first global marketing approval of tofacitinib for the treatment of JIA. The total duration of an individual subject's participation may vary depending upon when they enter the trial.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
  • The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
  • Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
  • Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

Exclusion Criteria:

  • Systemic JIA (sJIA) with active systemic features other than active joints and elevated acute phase reactants, persistent oligoarthritis, and undifferentiated JIA.
  • Infections:

    1. Chronic infections.
    2. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug.
    3. Any treated infections within 2 weeks of baseline visit.
    4. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
    5. History of infected joint prosthesis with prosthesis still in situ.
  • History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500551

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 25 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01500551     History of Changes
Other Study ID Numbers: A3921145  2011-004915-22  JIA 
Study First Received: December 22, 2011
Last Updated: November 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Arthritis
Pediatric
Tofacitinib
Long-term
JIA
CP-690,550
Xeljanz

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016