Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01188655
First received: August 24, 2010
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

This observational study will be a documentation of the prescribing and administration practices of Enbrel® and their impact on ankylosing spondylitis patients outcome in a real life setting.


Condition Intervention
Spondylitis, Ankylosing
Drug: Enbrel

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Non-Interventional Study With Enbrel in Patients With Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving BASDAI 40 Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.


Secondary Outcome Measures:
  • Change From Baseline in BASDAI at Week 12 and 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.

  • Change From Baseline in the BASFI at Weeks 12 and 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

  • Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24 [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
    Measured using a 100mm VAS ranging from 0=very good to 100=very bad.

  • Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24 [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
    Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.

  • Mean Duration of Morning Stiffness [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
    Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).

  • Change From Baseline in ASQoL at Week 12 and Week 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
    ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).

  • Percentage of Participants Without Enthesitis [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Without Peripheral Arthritis [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Mean Occiput-to-wall Distance at Week 12 and Week 24 [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Spine Agility Function by Schober Test [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
    Schober test determines agility of lumbar spine. It measures participant's ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.

  • Spine Agility Function by Ott Test [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
    The Ott index determines the agility of the thoracic spine.


Enrollment: 89
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Group Enbrel Drug: Enbrel

The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits.

Other Name: etanercept

Detailed Description:

The study population will be described using standard descriptive statistics for demographic, clinical, medical, characteristics, as well as for standard health-related quality of life and functional disability questionnaires .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient cohort in this non-interventional study will reflect the kind of patients seen in routine clinical practice and will not be specifically pre-selected as it is the case in clinical studies.

Criteria

Inclusion Criteria:

  • Proven diagnosis of Ankylosing Spondylitisin accordance with local guidelines
  • Patients treated as an outpatient

Exclusion Criteria:

  • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®.
  • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localised infections.
  • Patients with sepsis or risk of sepsis should not be treated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188655

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01188655     History of Changes
Other Study ID Numbers: 0881X1-4456, B1801095
Study First Received: August 24, 2010
Results First Received: March 29, 2011
Last Updated: September 8, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Pfizer:
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014