Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01500551
Recruitment Status : Recruiting
First Posted : December 28, 2011
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 22, 2011
First Posted Date  ICMJE December 28, 2011
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE March 18, 2013
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
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 tp 8 years ]
Change History Complete list of historical versions of study NCT01500551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Physician global evaluation of disease activity at each visit. [ Time Frame: up to 8 years ]
  • Number of joints with active arthritis at each visit. [ Time Frame: up to 8 years ]
  • Number of joints with limitation of motion at each visit. [ Time Frame: up to 8 years ]
  • Index of inflammation (C‑reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. [ Time Frame: up to 8 years ]
  • Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. [ Time Frame: up to 8 years ]
  • 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 ]
  • 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 ]
  • JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. [ Time Frame: up to 8 years ]
  • JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. [ Time Frame: up to 8 years ]
  • 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 ]
  • 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 ]
  • 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 ]
  • In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit. [ Time Frame: up to 8 years ]
  • Eligibility of tapering defined per protocol for corticosteroids [ Time Frame: up to 8 years ]
  • Eligibility of tapering defined per protocol for methotrexate [ Time Frame: up to 8 years ]
  • Eligibility of tapering defined per protocol for leflunomide [ Time Frame: Up to 8 years ]
  • Eligibility of tapering defined per protocol for tofacitinib [ Time Frame: Up to 8 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • Physician global evaluation of disease activity. [ Time Frame: up to 8 years ]
  • Number of joints with active arthritis. [ Time Frame: up to 8 years ]
  • Number of joints with limitation of motion. [ Time Frame: up to 8 years ]
  • Index of inflammation (C reactive protein [CRP]). [ Time Frame: up to 8 years ]
  • Juvenile Arthritis Multidimensional Assessment Report (JAMAR). [ Time Frame: up to 8 years ]
  • Parent's or child evaluation of overall wellbeing (JAMAR Visual Analog Scale [VAS] component). [ Time Frame: up to 8 years ]
  • Functional ability (JAMAR). [ Time Frame: up to 8 years ]
  • Health related quality of life (JAMAR). [ Time Frame: up to 8 years ]
  • American College of Rheumatology (ACR) pediatric response and flare criteria. [ Time Frame: up to 8 years ]
  • Inactive disease status parameters. [ Time Frame: up to 8 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis
Official Title  ICMJE A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
Brief Summary Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
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 340 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE
  • 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.

    5 mg BID Dose Level:

    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
  • Drug: Tofacitinib

    For participants rolling over from study A3921165: 10 mg BID Dose Level

    Body Weight (Dose in tablet [mg BID] or solution [ml BID])

    5 ‑ < 7 kg (4 mg or 4 ml) 7 - < 10 kg (5 mg or 5 ml) 10 - <15 kg (6 mg or 6 ml) 15 - <25 kg (7 mg or 7 ml) 25 - <40 kg (8 mg or 8 ml) >=40 kg (10 mg or 10 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
Study Arms  ICMJE Experimental: Tofacitinib
All patients will be in tofacitinib treatment group.
Interventions:
  • Drug: Tofacitinib
  • Drug: Tofacitinib
  • Drug: Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
340
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2011)
290
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Germany,   Israel,   Mexico,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Hungary,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT01500551
Other Study ID Numbers  ICMJE A3921145
2011-004915-22 ( EudraCT Number )
JIA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP