N/A
N=403
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01329380 ↗Enrolled (actual)
403
Serious AEs
4.3%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions — 101; 15 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reactions |
101; 15 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions by Baseline Factors |
94; 7; 66; 35; 9; 36 | 0.0328 sig |
| PRIMARY Number of Participants With Adverse Events |
125; 17 | — |
| PRIMARY Number of Participants With Self-injection Errors |
1 | — |
| SECONDARY Number of Participants With Markedly Improved or Improved Rating |
257; 292; 333 | — |
| SECONDARY Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors |
291; 42; 232; 101; 25; 146 | — |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.9; -2.0 | — |
Summary
This study of adalimumab (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
Eligibility Criteria
Inclusion Criteria
- Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab 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
Data sourced from ClinicalTrials.gov (NCT01329380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.