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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 : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Tofacitinib Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Intervention 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)
Actual Study Start Date : March 18, 2013
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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

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




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. [ Time Frame: up to 8 years ]

Secondary Outcome Measures :
  1. Physician global evaluation of disease activity at each visit. [ Time Frame: up to 8 years ]
  2. Number of joints with active arthritis at each visit. [ Time Frame: up to 8 years ]
  3. Number of joints with limitation of motion at each visit. [ Time Frame: up to 8 years ]
  4. Index of inflammation (C‑reactive protein [CRP] and Erythrocyte Sedimentation Rate [ESR]) at each visit. [ Time Frame: up to 8 years ]
  5. Parent's Assessment of Physical Function (Childhood Health Assessment Questionnaire [CHAQ]Disability Index)at each visit. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: up to 8 years ]
  8. JIA American College of Rheumatology (ACR) response and occurrence of JIA ACR disease flare at each visit. [ Time Frame: up to 8 years ]
  9. JIA ACR Clinical Inactive Disease status and Clinical Remission on Medication at each visit. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: up to 8 years ]
  14. Eligibility of tapering defined per protocol for corticosteroids [ Time Frame: up to 8 years ]
  15. Eligibility of tapering defined per protocol for methotrexate [ Time Frame: up to 8 years ]
  16. Eligibility of tapering defined per protocol for leflunomide [ Time Frame: Up to 8 years ]
  17. Eligibility of tapering defined per protocol for tofacitinib [ Time Frame: Up to 8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Locations
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United States, Arizona
Phoenix Children's Hospital- Inpatient Pharmacy Not yet recruiting
Phoenix, Arizona, United States, 85016
Phoenix Children's Hospital Not yet recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Children's Hospital- Attention: Jill Hernandez Active, not recruiting
Little Rock, Arkansas, United States, 72202
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Loma Linda University Children'S Hospital Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Clinical Trials Center Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Eye Institute Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University General Pediatric Clinic - Meridian Active, not recruiting
Loma Linda, California, United States, 92354
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) Active, not recruiting
Loma Linda, California, United States, 92408
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) Active, not recruiting
San Bernardino, California, United States, 92408
Rady Children's Hospital Center for Pediatric Clinical Research Recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Education and Office Building Recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Research Pharmacy Recruiting
San Diego, California, United States, 92123
Rady Children's Hospital Rheumatology Clinic Recruiting
San Diego, California, United States, 92123
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
United States, Connecticut
Connecticut Children's Medical Center Pharmacy Recruiting
Hartford, Connecticut, United States, 06106
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
IDS Pharmacy Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Nicklaus Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
Johns Hopkins All Children's Hospital Not yet recruiting
Saint Pertersburg, Florida, United States, 33701
All Children's Hospital Speciality Physicians Not yet recruiting
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Children's Healthcare of Atlanta-Pediatric Research Center Recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Children's Specialty Services Recruiting
Atlanta, Georgia, United States, 30322
Augusta University Health Pharmacy Active, not recruiting
Augusta, Georgia, United States, 30912
Augusta University Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Lurie Children's Investigational Drug Pharmacy Recruiting
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
IU Health Investigational Drug Services Active, not recruiting
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children at IU Health Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Tufts Medical Center - Floating Hospital for Children Recruiting
Boston, Massachusetts, United States, 02111
United States, Minnesota
Explorer Clinic, University of Minnesota Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
United States, New Jersey
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Pharmacy Department Recruiting
Bronx, New York, United States, 10467
Cohen Children's Medical Center of New York Recruiting
Lake Success, New York, United States, 11042
Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Columbia University Medical Center-Herbert Irving Pavillion Recruiting
New York, New York, United States, 10031
United States, North Carolina
Pediatric Research Recruiting
Charlotte, North Carolina, United States, 20207
Levine Children's Specialty Center Recruiting
Charlotte, North Carolina, United States, 28203
Atrium Health- Investigational Drug Services Recruiting
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Legacy Emanuel Medical Center - Inpatient Pharmacy Recruiting
Portland, Oregon, United States, 97227
Randall Children's Hospital at Legacy Emanuel Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Dell Children's Medical Group, Dell Children's Medical Center Active, not recruiting
Austin, Texas, United States, 78723
Texas Children's Hospital- Clinical Care Center Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital- Clinical Research Center Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital- Investigational Pharmacy Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital- Main Hospital Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital/Baylor College of Medicine- Feigin Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital Pharmacy Recruiting
Salt Lake City, Utah, United States, 84113
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
United States, Washington
Seattle Children's Hospital Active, not recruiting
Seattle, Washington, United States, 98105
Argentina
Instituto CAICI SRL Recruiting
Rosario, Santa FE, Argentina, S2000PBJ
Centro Medico Privado de Reumatologia Recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Hospital Britanico de Buenos Aires Recruiting
Caba, Argentina, C1280AEB
Australia, New South Wales
The Children's Hospital at Westmead Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Victoria
The Royal Children's Hospital Active, not recruiting
Parkville, Victoria, Australia, 3052
Belgium
UZ Leuven - Gasthuisberg Recruiting
Leuven, Belgium, 3000
Brazil
SER - Serviços Especializados em Reumatologia Active, not recruiting
Salvador, Bahia, Brazil, 40150-150
CMIP - Centro Mineiro de Pesquisa Ltda Recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Hospital Pequeno Príncipe/ Active, not recruiting
Curitiba, Parana, Brazil, 80250-060
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Faculdade de Medicina da UNESP Recruiting
Botucatu, SAO Paulo, Brazil, 18618-686
Hospital de Clinicas da UNICAMP-Laboratorio de Reumatologia-L06 Not yet recruiting
Campinas, SAO Paulo, Brazil, 13083-881
Hospital de Clinicas da UNICAMP Not yet recruiting
Campinas, SAO Paulo, Brazil, 13083-888
Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG) Active, not recruiting
Rio de Janeiro, Brazil, 21941-912
SPDM - Associacao Paulista para o Desenvolvimento da Medicina Recruiting
Sao Paulo, Brazil, 04037-002
Instituto da Crianca do Hospital das Clinicas da FMUSP Recruiting
Sao Paulo, Brazil, 05409-011
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
Teck Acute Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z2H6
C & W Health Centre of BC Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
McGill University Health Center, Glen Site, Central Pharmacy Recruiting
Montreal, Quebec, Canada, H4A 3J1
McGill University Health Center, Glen Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Chile
Bioreuma Not yet recruiting
Concepcion, Chile, 4070280
China, Chongqing
Children's Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 401122
China
Children's Hospital Affiliated to Capital Institute of Pediatrics/Rheumatology Immunology Not yet recruiting
Beijing, China, 100020
Children's Hospital of Fudan University Not yet recruiting
Shanghai, China, 201102
Germany
PRI - Pediatric Rheumatology Research Institute GmbH Active, not recruiting
Bad Bramstedt, Germany, 24576
Gesundheit Nord gGmbH Not yet recruiting
Bremen, Germany, 28177
Hamburger Zentrum fur Kinder und Jugendrheumatologie Recruiting
Hamburg, Germany, 22081
Universitatsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Asklepios Klinik Sankt Augustin GmbH Recruiting
Sankt Augustin, Germany, 53757
Israel
Rambam Health Care Recruiting
Haifa, Israel, 3109601
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Chaim Sheba M.C Tel hashomer Recruiting
Ramat Gan, Israel, 52621
Mexico
Clínica de Investigacion en Reumatologia y Obesidad, S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44650
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64460
Sociedad de Beneficencia Espanola. A.C. Recruiting
San Luis Potosi, Mexico, 78250
Hospital Central "Dr. Ignacio Morones Prieto" Recruiting
San Luis Potosi, Mexico, 78290
Unidad de Investigaciones Reumatologicas A.C. Recruiting
San Luis Potosi, Mexico, 78290
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C. Recruiting
San Luis Potosí, Mexico, 78213
Poland
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego Active, not recruiting
Bydgoszcz, Poland, 85-667
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Recruiting
Krakow, Poland, 31-503
Klinika Kardiologii i Reumatologii Dzieciecej Recruiting
Lodz, Poland, 91-738
Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o. Not yet recruiting
Sosnowiec, Poland, 41-218
Russian Federation
FSBEI HE BSMU MoH RF Not yet recruiting
Ufa, Republic OF Bashkortostan, Russian Federation, 450008
Clinic of FSBEI HE BSMU MoH RF Not yet recruiting
Ufa, Republic OF Bashkortostan, Russian Federation, 450083
FSBEI HE "Kazan SMU" MoH RF Not yet recruiting
Kazan, Russian Federation, 420138
SAHI CRCH MoH TR Not yet recruiting
Kazan, Russian Federation, 420138
Federal State Budgetary Scientific Institution Not yet recruiting
Moscow, Russian Federation, 115522
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University) Recruiting
Moscow, Russian Federation, 119435
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University), Recruiting
Moscow, Russian Federation, 119991
FSAI "NMRCCH" of MOH Russia Recruiting
Moscow, Russian Federation, 119991
FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare Recruiting
Saint-Petersburg, Russian Federation, 194100
FSBEI HE Saratov SMU n.a. V.I.Razumovskiy MoH RF Not yet recruiting
Saratov, Russian Federation, 410012
FSBEI HE Saratov SMU n.a. V.I.Razumovskiy MoH RF Not yet recruiting
Saratov, Russian Federation, 410054
State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5" Active, not recruiting
Tolyatti, Russian Federation, 445039
State Budgetary Healthcare Institution of Sverdlovsk Region Not yet recruiting
Yekaterinburg, Russian Federation, 620149
Slovakia
Narodny ustav reumatickych chorob Recruiting
Piestany, Slovakia, 921 12
South Africa
Panorama Medical Centre Not yet recruiting
Panorama, Cape Town, South Africa, 7500
Emmed Research Not yet recruiting
Pretoria, Gauteng, South Africa, 0002
Spain
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario y Politecnico La Fe Recruiting
Valencia, Spain, 46026
Turkey
Hacettepe University Medical Faculty Active, not recruiting
Ankara, Turkey, 06100
Istanbul Medeniyet University Medical Faculty Active, not recruiting
Istanbul, Turkey, 34000
Istanbul University Cerrahpasa Medical Faculty Not yet recruiting
Istanbul, Turkey, 34098
Umraniye Training and Research Hospital Active, not recruiting
Istanbul, Turkey, 34764
Erciyes University Medical Faculty Not yet recruiting
Kayseri, Turkey, 38039
Ukraine
Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a. Not yet recruiting
Dnipro, Ukraine, 49006
Ivano-Frankivsk Regional Children's Clinical Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76014
State Institution "Institute of Children and Adolescents Health Care" of the NAMS of Ukraine Not yet recruiting
Kharkiv, Ukraine, 61153
Communal Institution of Lviv Regional Council Not yet recruiting
Lviv, Ukraine, 79035
Vinnytsia Regional Children's Clinical Hospital Recruiting
Vinnitsya, Ukraine, 21000
United Kingdom
Birmingham Woman's and Children's NHS Foundation Trust Active, not recruiting
Birmingham, WEST Midlands, United Kingdom, B4 6NH
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01500551     History of Changes
Other Study ID Numbers: A3921145
2011-004915-22 ( EudraCT Number )
JIA ( Other Identifier: Alias Study Number )
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
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
Keywords provided by Pfizer:
Arthritis
Pediatric
Tofacitinib
Long-term
JIA
CP-690,550
Xeljanz
Additional relevant MeSH terms:
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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