Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

NCT00900796 | Completed Results

• 2 other identifiers: 0881A3-4452B1801100
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis;predictive factors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment

  Week 32

• Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment

  Week 32

• Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16

  Week 16

• Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16

  Week 16

• Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy

  Week 16

Study Arms (1)

1

Patients diagnosed with active AS who start anti-TNF therapy according to standard clinical practice.

Other: Treatment switching

Interventions

Treatment switching OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active ankylosing spondylitis treated in rheumatology units

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Treatment Switching

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 19, 2012
• Results First Posted: June 19, 2012

Record last verified: 2012-05

Locations

ES (1)