BridgeMD
A Long-Term, Open-Label, Study for Treatment of JIA
EU CTIS ID: 2023-509651-14-00
What this study is testing
The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- JIA subjects aged 2 to <18 years who met entry criteria for qualifying/index study with sufficient JIA disease activity to use tofacitinib.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects for whom, in the Investigator's opinion, treatment with tofacitinib is considered clinically appropriate. Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet the below:
- No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as defined in the protocol.
- Discontinuation of disallowed concomitant medications for the required time prior to first dose of study drug and only taking concomitant medications in allowable doses/frequencies.
- Fertile male 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 throughout the study and for at least 28 days after the last dose of study drug.
You likely can't join if
- For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study (Exclusion 1-3): Blood dyscrasas, including: a. Hgb <10 g/dL or Hct <33%. b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. e. Lymphocyte count of <0.75 x 109/L.
- Subjects taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix 6).
- Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).
- Participation in studies of investigational compounds (excluding qualifying/index study with tofacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Subjects cannot participate in studies of other investigational compounds at any time during their participation in this study. Exposure to investigational biologics should be discussed with the Pfizer Medical Monitor
- Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg, almetuzumab (CAMPATH®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
- Pregnant or nursing females are excluded.
See the full eligibility criteria
Who can join
- JIA subjects aged 2 to <18 years who met entry criteria for qualifying/index study with sufficient JIA disease activity to use tofacitinib.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects for whom, in the Investigator's opinion, treatment with tofacitinib is considered clinically appropriate. Subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study must also meet the below:
- No evidence of active tuberculosis (TB) or inadequately treated tuberculosis (TB) infection (active or latent) as defined in the protocol.
- Discontinuation of disallowed concomitant medications for the required time prior to first dose of study drug and only taking concomitant medications in allowable doses/frequencies.
- Fertile male 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 throughout the study and for at least 28 days after the last dose of study drug.
- Previously completed participation in a qualifying JIA study of tofacitinib.
- If receiving MTX, use of MTX orally or parenterally at doses not to exceed 25 mg/week or 20 mg/m2/week, whichever is lower. Must also take folic acid/folinic acid in accordance with local standards.
- If receiving an oral glucocorticoid, use of glucocorticoids at a max dose of 0.20 mg/kg/day or 10 mg/day, prednisone or equivalent, whichever is lower. For A3921165 subjects, a higher prednisone equivalent dose may be continued or started
- If receiving leflunomide treatment, use of leflunomide at the following doses: 10 mg every other day for subjects weighing 40 kg; Or as according to local standards.
- If receiving sulfasalazine, chloroquine, or hydroxychloroquine treatment, administer according to local standards.
- Evidence of a personally signed/dated ICD with assent as appropriate indicating that the subject (or a legally acceptable representative/parent(s)/legal guardian) has been informed of all aspects of the study.
What rules you out
- For subjects who enroll outside the 14 day window of the EOS Visit of their qualifying/index study (Exclusion 1-3): Blood dyscrasas, including: a. Hgb <10 g/dL or Hct <33%. b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. e. Lymphocyte count of <0.75 x 109/L.
- Subjects taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix 6).
- Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).
- Participation in studies of investigational compounds (excluding qualifying/index study with tofacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Subjects cannot participate in studies of other investigational compounds at any time during their participation in this study. Exposure to investigational biologics should be discussed with the Pfizer Medical Monitor
- Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg, almetuzumab (CAMPATH®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
- Pregnant or nursing females are excluded.
- Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of study medication (oral cortico steroids permitted as per inclusion criterion).
- Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication. All study participants should be up-to-date with respect to standard of care vaccinations (as defined by their country health ministry). (See Life Style Guidelines for further information regarding avoidance of household contacts who may be vaccinated).
- Use of prohibited prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- Herbal supplements must be discontinued at least 4 weeks prior to the first dose of study medication.
- Subjects with a first degree relative with a hereditary immunodeficiency; IgA deficiency not exclusionary.
- Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using Bedside Schwartz formula (Appendix 5) at the Screening Visit.
- Subjects with a malignancy or with a history of malignancy with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. See Protocol Section 4.2 for additional exclusion criteria.
- Aspartate aminotransferase (AST) or alanine inotransferase (ALT) ³1.5 times the upper limit of normal or any other clinically significant laboratory abnormality.
- For all subjects: Persistent oligoarthritis, and undifferentiated JIA.
- Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.
- History of any other rheumatic autoimmune disease, other than Sjogren's syndrome.
- History or current symptoms suggestive of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
- Infections: a) Chronic infections. b) 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: c) Any treated infections within 2 weeks of baseline visit. (excluding those treated with topicals only) d) A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.e.History of infected joint prosthesis with prosthesis still in situ.
- History of recurrent (more than one episode) herpes zoster or a single episode of disseminated herpes zoster or a single episode of disseminated (both oral and gential lesions simutaneously, or widespread lesions not contaminaed to oral or gential regions alone) herpes simplex.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Mexico
- Canada
- South Africa
- Argentina
- Russian Federation
- India
- China
- Israel
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; Mexico; Canada; South Africa; Argentina; Russian Federation and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.