Study 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.

For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.

The total duration of an individual subject's participation may vary depending upon when they enter the trial.

Condition or Disease	Intervention/Treatment
Juvenile Idiopathic Arthritis	Drug: Tofacitinib Drug: Tofacitinib

Study Design

Study Type	Interventional
Actual Enrollment	276 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
Study Start Date	March 18, 2013
Anticipated Primary Completion Date	March 22, 2025
Anticipated Study Completion Date	March 22, 2025

Groups and Cohorts

Group/ Cohort

Intervention/ Treatment

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 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.

Outcome Measures

Primary Outcome Measures

1. Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development. [up to 8 years]

Secondary Outcome Measures

1. Physician global evaluation of disease activity at each visit. [up to 8 years]
2. Number of joints with active arthritis at each visit. [up to 8 years]
3. Number of joints with limitation of motion at each visit. [up to 8 years]
4. Index of inflammation (C-reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. [up to 8 years]
5. Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. [up to 8 years]
6. Parent's Assessment of Child's Arthritis Pain (Childhood Health Assessment Questionnaire [CHAQ] Discomfort Index, Visual Analog Scale [VAS])at each visit. [up to 8 years]
7. Parent's Global Assessment of Overall Wellbeing (Childhood Health Assessment Questionnaire [CHAQ] subsection, Visual Analog Scale [VAS])at each visit. [up to 8 years]
8. JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. [up to 8 years]
9. JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. [up to 8 years]
10. 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. [up to 8 years]
11. 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. [up to 8 years]
12. 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. [up to 8 years]
13. In subjects with sJIA: "Absence of Fever", defined as absence of fever due to sJIA in the week preceding the assessment at each visit. [up to 8 years]
14. Eligibility of tapering defined per protocol for corticosteroids [up to 8 years]
15. Eligibility of tapering defined per protocol for methotrexate [up to 8 years]
16. Eligibility of tapering defined per protocol for leflunomide [Up to 8 years]
17. Eligibility of tapering defined per protocol for tofacitinib [Up to 8 years]

Eligibility Criteria

Ages Eligible for Study	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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	persistent oligoarthritis, and undifferentiated JIA. Infections: Chronic infections. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug. Any treated infections within 2 weeks of baseline visit. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus. 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

Sponsors and Collaborators	Pfizer
Locations	Phoenix Children's Hospital- Inpatient Pharmacy | Phoenix, Arizona, United States, 85016 Phoenix Children's Hospital | Phoenix, Arizona, United States, 85016 Arkansas Children's Hospital | Little Rock, Arkansas, United States, 72202 Loma Linda University Children'S Hospital | Loma Linda, California, United States, 92354 Loma Linda University Clinical Trials Center | Loma Linda, California, United States, 92354 Loma Linda University Eye Institute | Loma Linda, California, United States, 92354 Loma Linda University General Pediatric Clinic - Meridian | Loma Linda, California, United States, 92354 Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) | Loma Linda, California, United States, 92408 Children's Hospital Los Angeles | Los Angeles, California, United States, 90027 Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) | San Bernardino, California, United States, 92408 Rady Children's Hospital Center for Pediatric Clinical Research | San Diego, California, United States, 92123 Rady Children's Hospital Education and Office Building | San Diego, California, United States, 92123 Rady Children's Hospital Research Pharmacy | San Diego, California, United States, 92123 Rady Children's Hospital Rheumatology Clinic | San Diego, California, United States, 92123 Rady Children's Hospital San Diego- Education and Office Building | San Diego, California, United States, 92123 Rady Children's Hospital San Diego | San Diego, California, United States, 92123 Rady Children's Research Pharmacy | San Diego, California, United States, 92123 Connecticut Children's Medical Center | Hartford, Connecticut, United States, 06106 Children's National Medical Center | Washington, District of Columbia, United States, 20010 IDS Pharmacy | Washington, District of Columbia, United States, 20010 Nicklaus Children's Hospital | Miami, Florida, United States, 33155 AdventHealth | Orlando, Florida, United States, 32803 AdventHealth Investigational Drug Services | Orlando, Florida, United States, 32804 AdventHealth Pediatric Outpatient Procedures and Sedation | Orlando, Florida, United States, 32804 AHMG Pediatric Rheumatology and Immunology | Orlando, Florida, United States, 32804 Johns Hopkins All Children's Hospital | Saint Pertersburg, Florida, United States, 33701 All Children's Hospital Speciality Physicians | Saint Petersburg, Florida, United States, 33701 Center for Advanced Pediatrics | Atlanta, Georgia, United States, 30329 AU Medical Center | Augusta, Georgia, United States, 30912 Augusta University Health Pharmacy | Augusta, Georgia, United States, 30912 Augusta University | Augusta, Georgia, United States, 30912 Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago, Illinois, United States, 60611 Lurie Rheumatology Offices | Chicago, Illinois, United States, 60611 The University of Chicago Medical Center | Chicago, Illinois, United States, 60637 Riley Hospital for Children at IU Health | Indianapolis, Indiana, United States, 46202 Tufts Medical Center - Floating Hospital for Children | Boston, Massachusetts, United States, 02111 Explorer Clinic, University of Minnesota Children's Hospital | Minneapolis, Minnesota, United States, 55454 Hackensack University Medical Center | Hackensack, New Jersey, United States, 07601 Montefiore Medical Center | Bronx, New York, United States, 10467 Cohen Children's Medical Center of New York | Lake Success, New York, United States, 11042 Hospital for Special Surgery | New York, New York, United States, 10021 Columbia University Medical Center-Herbert Irving Pavillion | New York, New York, United States, 10032 UNC Children's Hospital | Chapel Hill, North Carolina, United States, 27514 UNC Clinical & Translational Research Unit | Chapel Hill, North Carolina, United States, 27599 Pediatric Research | Charlotte, North Carolina, United States, 20207 Levine Children's Specialty Center | Charlotte, North Carolina, United States, 28203 Atrium Health- Investigational Drug Services | Charlotte, North Carolina, United States, 28207 UNC Children's Raleigh | Raleigh, North Carolina, United States, 27607 Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States, 45229 University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, United States, 73104 Randall Children's Hospital at Legacy Emanuel | Portland, Oregon, United States, 97227 The Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States, 19104 Dell Children's Medical Group, Dell Children's Medical Center | Austin, Texas, United States, 78723 Texas Children's Hospital- Clinical Care Center | Houston, Texas, United States, 77030 Texas Children's Hospital- Clinical Research Center | Houston, Texas, United States, 77030 Texas Children's Hospital- Investigational Pharmacy | Houston, Texas, United States, 77030 Texas Children's Hospital- Main Hospital | Houston, Texas, United States, 77030 Texas Children's Hospital/Baylor College of Medicine- Feigin Center | Houston, Texas, United States, 77030 Intermountain - Primary Children's Hospital | Salt Lake City, Utah, United States, 84113 Seattle Children's Hospital | Seattle, Washington, United States, 98105 Instituto CAICI SRL | Rosario, Santa FE, Argentina, S2000PBJ Centro Medico Privado de Reumatologia | San Miguel de Tucuman, Tucuman, Argentina, T4000AXL Hospital Britanico de Buenos Aires | Caba, Argentina, C1280AEB The Children's Hospital at Westmead | Westmead, New South Wales, Australia, 2145 The Royal Children's Hospital | Parkville, Victoria, Australia, 3052 Queen Fabiola Children's University Hospital | Brussels, Belgium, 1020 UZ Gent | Gent, Belgium, 9000 UZ Leuven - Gasthuisberg | Leuven, Belgium, 3000 SER - Serviços Especializados em Reumatologia | Salvador, Bahia, Brazil, 40150-150 CMIP - Centro Mineiro de Pesquisa Ltda | Juiz de Fora, Minas Gerais, Brazil, 36010-570 Hospital Pequeno Príncipe Clinical Research Office | Curitiba, Parana, Brazil, 80250-060 Hospital Pequeno Príncipe/ | Curitiba, Parana, Brazil, 80250-060 Hospital de Clínicas de Porto Alegre | Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903 Faculdade de Medicina da UNESP | Botucatu, SAO Paulo, Brazil, 18618-686 Hospital de Clinicas da UNICAMP-Laboratorio de Reumatologia-L06 | Campinas, SAO Paulo, Brazil, 13083-881 Hospital de Clinicas da UNICAMP | Campinas, SAO Paulo, Brazil, 13083-888 Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG) | Rio de Janeiro, Brazil, 21941-912 SPDM - Associacao Paulista para o Desenvolvimento da Medicina | Sao Paulo, Brazil, 04037-002 Instituto da Crianca do Hospital das Clinicas da FMUSP | Sao Paulo, Brazil, 05409-011 Alberta Children's Hospital | Calgary, Alberta, Canada, T3B 6A8 Teck Acute Care Centre | Vancouver, British Columbia, Canada, V5Z2H6 C & W Health Centre of BC | Vancouver, British Columbia, Canada, V6H 3N1 British Columbia Children's Hospital | Vancouver, British Columbia, Canada, V6H 3V4 The Hospital for Sick Children | Toronto, Ontario, Canada, M5G 1X8 McGill University Health Center, Glen Site, Central Pharmacy | Montreal, Quebec, Canada, H4A 3J1 McGill University Health Center, Glen Site | Montreal, Quebec, Canada, H4A 3J1 Children's Hospital of Chongqing Medical University | Chongqing, Chongqing, China, 401122 Guangzhou Women and Children's Medical Center | Guangzhou, Guangdong, China, 510623 Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan, Hubei, China, 430030 The Second Xiangya Hospital of Central South University | Changsha, Hunan, China, 410011 Children's Hospital of Soochow University | Suzhou, Jiangsu, China, 215003 Xi'an Children's Hospital | Xi'an, Shaanxi, China, 710003 Chengdu Women's and Children's Central Hospital | Chengdu, Sichuan, China, 610073 The Children's Hospital Zhejiang University School of Medicine | Hangzhou, Zhejiang, China, 310057 Beijing Children's Hospital, Capital Medical University/Rheumatology Department | Beijing, China, 100045 Children's Hospital of Fudan University | Shanghai, China, 201102 Hospital Metropolitano | San Jose, Costa Rica, 10103 Universitaetsklinikum Erlangen Kinder- und Jugendklinik | Erlangen, Bayern, Germany, 91054 PRI - Pediatric Rheumatology Research Institute GmbH | Bad Bramstedt, Germany, 24576 HELIOS Klinikum Berlin-Buch | Berlin, Germany, 13125 Universitaets-Kinderklinik Charite SPZ Kinderrheumatologie | Berlin, Germany, 13353 Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik | Bremen, Germany, 28177 Klinikum Bremen-Mitte | Bremen, Germany, 28177 Universitaetsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik fur Kinder-und Jugendmedizin | Dresden, Germany, 01307 Deutsches Zentrum für Kinder- und Jugendrheumatologie | Garmisch-partenkirchen, Germany, 82467 Hamburger Zentrum fur Kinder und Jugendrheumatologie | Hamburg, Germany, 22081 Asklepios Klinik Sankt Augustin GmbH | Sankt Augustin, Germany, 53757 St. Josef-Stift Sendenhorst | Sendenhorst, Germany, 48324 Semmelweis Egyetem | Budapest, Hungary, 1094 Nirmal Hospital Pvt Ltd. | Surat, Gujarat, India, 395002 Institute of Child Health | Kolkata, WEST Bengal, India, 700017 Institute of Post Graduate Medical Education and Research & SSKM Hospital | Kolkata, WEST Bengal, India, 700020 Sir Ganga Ram Hospital | New Delhi, India, 110060 Rambam Health Care Campus | Haifa, Israel, 31096 01 Rambam Health Care | Haifa, Israel, 3109601 Meir Medical Center - Pediatric Clinic | Kfar Saba, Israel, 4428164 Meir Medical Center | Kfar Saba, Israel, 4428164 Chaim Sheba M.C Tel hashomer | Ramat Gan, Israel, 52621 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, Milan, Italy, 20122 IRCCS Giannina Gaslini Department/Division | Genova, Italy, 16147 Clínica de Investigacion en Reumatologia y Obesidad, S.C. | Guadalajara, Jalisco, Mexico, 44650 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey, Nuevo LEON, Mexico, 64460 Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C. | San Luis De Potosí, Mexico, 78213 Hospital Central "Dr. Ignacio Morones Prieto" | San Luis Potosi, Mexico, 78290 Unidad de Investigaciones Reumatologicas A.C. | San Luis Potosi, Mexico, 78290 Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego | Bydgoszcz, Poland, 85-667 Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie | Krakow, Poland, 31-503 Klinika Kardiologii i Reumatologii Dzieciecej | Lodz, Poland, 91-738 Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o. | Sosnowiec, Poland, 41-218 WIP Warsaw IBD Point Profesor Kierkus | Warszawa, Poland, 00-728 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher | Warszawa, Poland, 02-637 FSBEI HE BSMU MoH RF | Ufa, Republic OF Bashkortostan, Russian Federation, 450008 Clinic of FSBEI HE BSMU MoH RF | Ufa, Republic OF Bashkortostan, Russian Federation, 450083 Federal State Budgetary Scientific Institution | Moscow, Russian Federation, 115522 FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University) | Moscow, Russian Federation, 119435 FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University), | Moscow, Russian Federation, 119991 FSAI "NMRCCH" of MOH Russia | Moscow, Russian Federation, 119991 FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare | Saint-Petersburg, Russian Federation, 194100 State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5" | Tolyatti, Russian Federation, 445039 Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH | Bratislava, Slovakia, 83340 Detska Fakultna nemocnica Kosice | Kosice, Slovakia, 04011 Narodny ustav reumatickych chorob | Piestany, Slovakia, 921 12 Panorama Medical Centre | Panorama, Cape Town, South Africa, 7500 Enhancing Care Foundation | Durban, Kwazulu-natal, South Africa, 4302 Durban International Clinical Research Site, Enhancing Care Foundation | Durban, South Africa, 4301 Hospital Universitario Ramon y Cajal | Madrid, Spain, 28034 Hospital Universitario La Paz | Madrid, Spain, 28046 Hospital Universitario y Politecnico La Fe | Valencia, Spain, 46026 Hacettepe University Medical Faculty | Ankara, Turkey, 06100 Istanbul University Cerrahpasa Medical Faculty | Istanbul, Turkey, 34098 Umraniye Training and Research Hospital | Istanbul, Turkey, 34764 Umraniye Training and Research Hospital | Istanbul, Turkey, 35767 Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu | Kadikoy / Istanbul, Turkey, 34722 Erciyes University Medical Faculty | Kayseri, Turkey, 38039 Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a. | Dnipro, Ukraine, 49006 Ivano-Frankivsk Regional Children's Clinical Hospital | Ivano-Frankivsk, Ukraine, 76014 Communal Non-profit Enterprise | Vinnytsia, Ukraine, 21000 Birmingham Woman's and Children's NHS Foundation Trust | Birmingham, WEST Midlands, United Kingdom, B4 6NH NHS Greater Glasgow and Clyde Royal Hospital for Children | Glasgow, United Kingdom, G51 4TF
Investigators

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Additional Information

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Additional Relevant MeSH Terms

• Arthritis
• Arthritis, Juvenile
• Joint Diseases
• Musculoskeletal Diseases
• Rheumatic Diseases
• Connective Tissue Diseases
• Autoimmune Diseases
• Immune System Diseases