Crohn’s Disease
Conditions
Interventions
Study sites:
1. Colombo North Teaching Hospital, Ragama.
2. Kandy Teaching Hospital, Kandy
Interventions: Subjects who exit a parent study due to disease worsening or failure to meet response or remi
Sponsors
Gilead Sciences, Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial 2. Must have met all eligibility criteria from trial SLCTR/2018/029. 3. Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment 4. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6 of the protocol for the duration described 5. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug 6. Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for Crohn’s Disease - SLCTR/2018/029
Exclusion criteria
Exclusion criteria: 1. Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study. Details of discontinuation are provided as an annexure. 2. Known hypersensitivity to the study drug 3. Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol 4. Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug 5. Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug 6. Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in Appendix 6 of the protocol 7. Use of prohibited medications as outlined in Section 5.4 of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests. 1. Clinical parameters • Resting blood pressure • Respiratory rate • Pulse • Temperature [Day 1, week 2, week 4, Week 12 and then every 12 Weeks from Day 1 Clinic Visit, early termination visit, post treatment. ] Hematology and chemistry Hematology • Hematocrit • Hemoglobin • Platelet count • Red blood cell (RBC) count • White blood cell (WBC) count • Differentials (absolute and percentage), including: • Lymphocytes • Monocytes • Neutrophils • Eosinophils • Basophils • Reticulocyte count • Mean corpuscular volume (MCV) Chemistry • Alkaline phosphatase • Aspartate aminotransferase(AST) • Alanine aminotransferase (ALT) • Total bilirubin • Direct and indirect bilirubin • Total protein • Albumin • Bicarbonate • Blood urea nitrogen (BUN) • Calcium • Chloride • Serum creatinine • Creatinine clearance CC&G • Glucose • Phosphorus • Magnesium • Potassium • Sodium • Creatine Phosphokinase (CPK) [Hematology and chemistry Day 1, Week 2, Week 4, Week 12 and then every 12 weeks from Day 1 visit, Early termination visit day, Post-treatment day ] Lipid profile (fasting) [ Every 24 weeks from Day 1 Clinic Visit] Urinalysis [ Day 1, Every 24 weeks from Day 1 Clinic Visit] Pregnancy test [ Day 1, Week 4, Every 4 weeks from Day 1,Early termination visit day, Post-treatment day] Serum immunoglobulin [ Day 1, Every 24 weeks from Day 1] CRP [ Day 1, Every 24 weeks from Day 1] Fecal MMP-9 [ Day 1, Every 24 weeks from Day 1] Fecal Calprotectin, and Lactoferrin [ Day 1, Every 24 weeks from Day 1] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in PRO2 Scores. PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency. [From Baseline in PRO2 Scores from Baseline and up to 144 weeks. ] Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [From Baseline and up to 144 weeks] | — |
Countries
Australia,Austria,Belgium,Bulgaria,Canada,Croatia,France,Germany,Greece,Hong Kong,Hungary,Iceland,India,Ireland,Israel,Italy,Japan,Korea, Republic of,Malaysia,Mexico,Netherlands,New Zealand,Poland,Por
Contacts
Public ContactProf Arjuna de Silva
Consultant Physician
Outcome results
None listed