Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00544557
First received: October 15, 2007
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Etanercept
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Partial Remission at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.

  • Percentage of Participants Achieving Partial Remission at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.


Secondary Outcome Measures:
  • Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.

  • Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem).

  • Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).

  • Change From Baseline in Occiput-to-Wall Distance at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.

  • Change From Baseline in Lateral Lumbar Flexion at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.

  • Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

  • Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

  • Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).

  • Change From Baseline in Duration of Morning Stiffness at Week 52 [ Time Frame: Baseline, Week 52 ] [ 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.

  • Percentage of Participants With Significant Reduction of Morning Stiffness [ Time Frame: Week 2, 6, 12, 26, 38, 52 ] [ 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. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).

  • Percentage of Participants With Presence of Peripheral Arthritis [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.

  • Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.

  • Percentage of Participants With Presence of Enthesitis [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.

  • Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.

  • Change From Baseline in C-Reactive Protein (CRP) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  • Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

  • Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response [ Time Frame: Week 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

  • Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response [ Time Frame: Week 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.

  • Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.

  • Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.

  • Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

  • Healthcare Resource Utilization [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.

  • Duration of Healthcare Resources Utilization [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.

  • Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: Yes ]
    Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.

  • Percentage of Participants With Discontinuation of Treatment Due to Adverse Events [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.


Enrollment: 1715
Study Start Date: October 2007
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Ankylosing Spondylitis Drug: Etanercept
The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Other Name: Enbrel

Detailed Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

  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

Patients with an established diagnosis of Ankylosing Spondylitis

Criteria

Inclusion Criteria:

  • Diagnosis of ankylosing spondylitis (AS)

Exclusion Criteria:

  • Hypersensitivity to etanercept
  • Active infection including chronic or localised infection
  • Sepsis or risk of sepsis
  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: NCT00544557

Locations
Germany
Klinikum Benjamin Franklin
Berlin, Germany, 12200
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: NCT00544557     History of Changes
Other Study ID Numbers: 0881X1-4463, B1801087
Study First Received: October 15, 2007
Results First Received: April 23, 2015
Last Updated: April 23, 2015
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 30, 2015