Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

Completed

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT01329380
• Lead Sponsor: AbbVie

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-27
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Primary Completion: 2017-12-28
• Study Completion: 2017-12-28
• Status Verified: 2018-12
• Results First Submitted: 2018-12-20
• Results First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Results First Posted: 2019-04-03
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	24 weeks	An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown.; A serious adverse drug reaction is any untoward medical occurrence that at any dose; * Results in death; * Life threatening; * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent of significant disability or incapacity
Number of Participants With Adverse Drug Reactions by Baseline Factors	24 weeks	An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics.; NSAID: non-steroidal anti-inflammatory drug; DMARD: disease-modifying anti-rheumatic drug; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index
Number of Participants With Self-injection Errors	24 weeks
Number of Participants With Adverse Events	24 weeks	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.; A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Markedly Improved or Improved Rating	Weeks 12, 24, and at the last visit	Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors	24 weeks (or last visit if earlier)	Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Baseline and weeks 12 and 24	The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.

Trial Locations

Locations (193)

Nagoya City University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Kurume University Hospital; 🇯🇵 Kurume-shi, Fukuoka, Japan

Gunma University Hospital; 🇯🇵 Maebashi-shi, Gunma, Japan

Hyogo College of Medicine Hosp; 🇯🇵 Nishinomiya, Hyogo, Japan

Yokohama City Univ Medical Ctr; 🇯🇵 Yokohama, Kanagawa, Japan

Nagasaki University Hospital; 🇯🇵 長崎市, Nagasaki, Japan

Okayama University Hospital; 🇯🇵 Okayama-shi, Okayama, Japan

Osaka City University Hospital; 🇯🇵 大阪市, Osaka, Japan

Saitama Medical Center; 🇯🇵 Kawagoe, Saitama, Japan

Shiga Univ Med Science Hosp; 🇯🇵 Otsu, Shiga, Japan

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