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A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis (TORTUGA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03117270
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date August 13, 2018
Actual Study Start Date  ICMJE March 7, 2017
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
To evaluate the effect of filgotinib on the AS disease activity score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To evaluation the effect of filgotinib on the ASAS score in AS patients
  • Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient
  • Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS disease activity index in AS patients
  • Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS functional index in AS patients
  • Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS metrology index in AS patients
  • Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients
  • Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients
  • Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on FACIT fatigue scale in AS patients
  • Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on SF-36 health survey in AS patients
  • Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on ASQoL in AS patients
  • Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events [ Time Frame: from baseline until the final follow up visit (week 16) ]
    To assess safety and tolerability of filgotinib in AS patients
  • Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations [ Time Frame: from baseline until the final follow up visit (week 16) ]
    To assess safety and tolerability of filgotinib in AS patients
  • Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs [ Time Frame: from baseline until the final follow up visit (week 16) ]
    To assess safety and tolerability of filgotinib in AS patients
  • Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination [ Time Frame: from baseline until the final follow up visit (week 16) ]
    To assess safety and tolerability of filgotinib in AS patients
  • Difference between the number of filgotinib treated subjects and placebo with abnormal ECG [ Time Frame: At baseline, end of study visit (week 12) and final follow up visit (week 16) ]
    To assess safety and tolerability of filgotinib in AS patients
  • Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment [ Time Frame: At baseline and end of study visit (week 12) ]
    To assess safety and tolerability of filgotinib in AS patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis
Brief Summary This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: filgotinib
    one filgotinib oral tablet q.d.
  • Drug: Placebo Oral Tablet
    one placebo oral tablet q.d.
Study Arms  ICMJE
  • Experimental: oral filgotinib tablets
    Intervention: Drug: filgotinib
  • Placebo Comparator: placebo tablets
    Intervention: Drug: Placebo Oral Tablet
Publications * van der Heijde D, Baraliakos X, Gensler LS, Maksymowych WP, Tseluyko V, Nadashkevich O, Abi-Saab W, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Mozaffarian N, Liu K, Greer JM, Deodhar A, Landewé R. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2378-2387. doi: 10.1016/S0140-6736(18)32463-2. Epub 2018 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2018)
116
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2017)
100
Actual Study Completion Date  ICMJE July 2, 2018
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male or female subjects who are ≥18 years of age on the day of signing informed consent.
  • Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria
  • Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
  • Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.
  • If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.
  • If using non-drug therapies (including physical therapies), these should be kept stable during screening.
  • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.

Key Exclusion Criteria:

  • Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
  • Prior use of more than one TNF inhibitor, at any time.
  • Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
  • Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
  • Use of more than 1 NSAID or COX-2 inhibitor.
  • Contraindication to MRI.
  • History of known or suspected complete ankylosis of the spine.
  • Presence of very poor functional status or unable to perform self-care.
  • Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
  • Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   Estonia,   Poland,   Spain,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03117270
Other Study ID Numbers  ICMJE GLPG0634-CL-223
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pille Harrison, MD, DPhil, MRCP (UK) Galapagos NV
PRS Account Galapagos NV
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP