Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01786668
First received: February 6, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Tofacitinib 2 mg
Drug: Tofacitinib 5 mg
Drug: Tofacitinib 10 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment in Ankylosing Spondylitis (ASAS) 20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change = 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for = 3 domains, and no worsening in remaining domain.


Secondary Outcome Measures:
  • Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score and/or modified Berlin Ankylosing Spondlylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the SI joints and spine [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Assessment in Ankylosing Spondylitis (ASAS) 20 [ Time Frame: Baseline, Week 2, Week 4, Week 8 ] [ Designated as safety issue: No ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change = 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for = 3 domains, and no worsening in remaining domain.

  • Assessment in Ankylosing Spondylitis (ASAS) 40 [ Time Frame: Baseline, Week 2, Week 4, Week 12 ] [ Designated as safety issue: No ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change = 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for = 3 domains, and no worsening in remaining domain.

  • Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
    ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in = 5 domains and no worsening in the remaining domain.

  • Achieving Ankylosing Spondlylitis Disease Activity Score using C-Reactive Protein (ASDAS(CRP)) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS) clinically important improvement [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS)major improvement [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Achieving Ankylosing Spondlylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.

  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Score [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

  • Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Extra-articular Involvement as assessed by swollen joints [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Spinal mobility as assessment by chest expansion [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Day 1 and Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (

  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tofacitinib 2 mg Drug: Tofacitinib 2 mg
4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Experimental: Tofacitinib 5 mg Drug: Tofacitinib 5 mg
4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Experimental: Tofacitinib 10 mg Drug: Tofacitinib 10 mg
4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of Ankylosing Spondylitis
  • Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs

Exclusion Criteria:

  • Pregnant or lactating females
  • Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786668

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 97 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01786668     History of Changes
Other Study ID Numbers: A3921119
Study First Received: February 6, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Ankylosing Spondylitis
Spondylitis
Ankylosing
Spondyloarthritis
Spondyloarthropathy
Oral preparation

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on July 20, 2014