Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

— PRETEA  

Official title:

Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900796
• Other study ID #: 0881A3-4452
• Secondary ID: B1801100
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 7, 2012
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

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

Locations

Country	Name	City	State
Spain	Pfizer Investigational Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Clinical Response	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.	Week 16	No
Secondary	Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment	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.	Week 32	No
Secondary	Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment	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.	Week 32	No
Secondary	Percentage of Participants With Low Probability of Response and a Clinical Response at 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.	Week 16	No
Secondary	Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at 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.	Week 16	No
Secondary	Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy		Week 16	No
Secondary	Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks	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.	Week 32	No

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