Trial record 15 of 50 for:    Open Studies | "Spondylitis, Ankylosing"

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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01786668
First received: February 6, 2013
Last updated: March 20, 2014
Last verified: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786668

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

  Show 75 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: March 20, 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 April 16, 2014