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Trial record 11 of 298 for:    "Ankylosing spondylitis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01329380
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Ankylosing Spondylitis

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Study Type : Observational
Actual Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
Actual Study Start Date : October 27, 2010
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Adalimumab
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.



Primary Outcome Measures :
  1. Number of Participants With Adverse Drug Reactions [ Time Frame: 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

  2. Number of Participants With Adverse Drug Reactions by Baseline Factors [ Time Frame: 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


  3. Number of Participants With Adverse Events [ Time Frame: 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.


  4. Number of Participants With Self-injection Errors [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Number of Participants With Markedly Improved or Improved Rating [ Time Frame: 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


  2. Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors [ Time Frame: 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


  3. Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive Humira for the treatment of ankylosing spondylitis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329380


  Show 194 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01329380     History of Changes
Other Study ID Numbers: P12-764
First Posted: April 5, 2011    Key Record Dates
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Ankylosing Spondylitis

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis