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 : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Drug: Tofacitinib||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)|
|Actual Study Start Date :||March 18, 2013|
|Estimated Primary Completion Date :||November 26, 2024|
|Estimated Study Completion Date :||November 26, 2024|
All patients will be in tofacitinib treatment group.
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 for all subjects for all three index studies (A3921103, A3921104, and A3921165)
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
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
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500551
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|