Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Sponsor AbbVie (prior sponsor, Abbott)
Start date November 2010
End date April 2016
Trial size 100 participants
Trial identifier NCT01329380, P12-764

Summary

This study of Humira will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

- Unknown adverse drug reactions (especially important adverse drug reactions)

- Incidence and conditions of occurrence of adverse reactions in the clinical setting

- Factors that may affect the safety and effectiveness of Humira

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
those with an exposure

Primary Outcomes

Measure
Number of patients with adverse events
time frame: at week 24
Bath ankylosing spondylitis Disease Activity Index
time frame: at week 12
Bath ankylosing spondylitis Disease Activity Index
time frame: at week 24

Secondary Outcomes

Measure
Effectiveness evaluation by the investigator
time frame: at week 12
Effectiveness evaluation by the investigator
time frame: at week 24

Eligibility Criteria

Male or female participants from 16 years up to 99 years old.

Inclusion Criteria: - All patients with Ankylosing Spondylitis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey Exclusion Criteria: - Contraindications according to the Package Insert - Patients who have serious infections - Patients who have tuberculosis - Patients with a history of hypersensitivity to any ingredient of Humira - Patients who have demyelinating disease or with a history of demyelinating disease - Patients who have congestive cardiac failure

Additional Information

Official title Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by AbbVie.