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Trial record 1 of 1 for:    NCT00900796
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Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis (PRETEA)

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ClinicalTrials.gov Identifier: NCT00900796
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 11, 2009
First Posted Date May 13, 2009
Results First Submitted Date May 7, 2012
Results First Posted Date June 19, 2012
Last Update Posted Date June 19, 2012
Study Start Date March 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2012)
Percentage of Participants With a Clinical Response [ Time Frame: Week 16 ]
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
Original Primary Outcome Measures
 (submitted: May 12, 2009)
Incidence of major clinical response (described by Davis and Rudwaleit) in patients at 16 weeks after starting anti-TNF therapy. Patients will be classified as responders or non responders, with inadequate response defined by Spanish Guidelines. [ Time Frame: 16 weeks ]
Change History Complete list of historical versions of study NCT00900796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 7, 2012)
  • Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment [ Time Frame: Week 32 ]
    High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.
  • Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment [ Time Frame: Week 32 ]
    Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
  • Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16 [ Time Frame: Week 16 ]
    Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator's criteria.
  • Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 [ Time Frame: Week 16 ]
    ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
  • Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy [ Time Frame: Week 16 ]
  • Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks [ Time Frame: Week 32 ]
    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 of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.
Original Secondary Outcome Measures
 (submitted: May 12, 2009)
  • Percentage of patients with no response who receive a 2nd anti-TNF for at least 16 weeks. [ Time Frame: 42 weeks ]
  • ASAS40 response at 16 weeks after starting anti-TNFs. [ Time Frame: 42 weeks ]
  • Percentage of patients who switch to another anti-TNF due to inefficacy [ Time Frame: 42 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
Official Title Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
Brief Summary The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
Detailed Description A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with active ankylosing spondylitis treated in rheumatology units
Condition Ankylosing Spondylitis
Intervention Other: Treatment switching
If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria
Study Groups/Cohorts 1
Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice.
Intervention: Other: Treatment switching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2012)
132
Original Estimated Enrollment
 (submitted: May 12, 2009)
240
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.
  • >18 years, both genders, any disease duration
  • Signature of informed consent

Exclusion Criteria:

  • Previous treatment with biological therapies
  • Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00900796
Other Study ID Numbers 0881A3-4452
B1801100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012