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Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474876
First Posted: November 18, 2011
Last Update Posted: July 8, 2015
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
November 16, 2011
November 18, 2011
May 18, 2015
July 8, 2015
July 8, 2015
November 2011
May 2014   (Final data collection date for primary outcome measure)
  • Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline [ Time Frame: Baseline (Visit 0) to 12 months ]
    The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.
  • Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline [ Time Frame: Baseline (Visit 0) to 12 months ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
  • Percentage of Participants With Active Axial Symptoms in Remission [ Time Frame: Baseline (Visit 0) to 12 months ]
    The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.
  • Percentage of Participants With Peripheral Symptoms in Remission [ Time Frame: Baseline (Visit 0) to 12 months ]
    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.
  • Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) score [ Time Frame: Day 0 to 12 months ]
    Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined by at least 50% from baseline in case of axial symptoms.
  • Disease Activity Score/28 joints (DAS28) [ Time Frame: Day 0 to 12 months ]
    Primary endpoint is the percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined as a decrease by at least 1.2 from baseline in case of peripheral symptoms.
  • Ankylosing Spondylitis Disease Score (ASDAS) score [ Time Frame: Day 0 to 12 months ]
    Co-primary endpoint is the percentage of patients in remission at the end of the observational period of 12 months. Remission is defined as a score of < 1.3 in case of axial symptoms (which corresponds to Assessment in Ankylosing Spondylitis ASAS partial remission PR criterion).
  • Disease Activity Score/28 joints (DAS28) [ Time Frame: Day 0 to 12 months ]
    Co-primary endpoint is the percentage of patients in remission at the end of the observational period of 12 months. Remission is defined as a score of <=2.6 in case of peripheral symptoms.
Complete list of historical versions of study NCT01474876 on ClinicalTrials.gov Archive Site
  • Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis [ Time Frame: Baseline (Visit 0) to 12 months ]

    The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

  • Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Baseline (Visit 0) to 12 months ]
    The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.
  • Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis [ Time Frame: Baseline (Visit 0) to 12 months ]
    BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).
  • Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis [ Time Frame: Baseline (Visit 0) to 12 months ]
    A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.
  • Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis [ Time Frame: Baseline (Visit 0) to 12 months ]
    HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.
  • Mean Frequency of Extra-articular Manifestations (EAMs) [ Time Frame: Baseline (Visit 0) to 12 months ]
    Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Duration of Treatment With Adalimumab [ Time Frame: Baseline (Visit 0) to 12 months ]
    The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.
  • Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study [ Time Frame: Baseline (Visit 0) to 12 months ]
    Participants were surveyed at each study visit for their use of NSAID medication.
  • Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis [ Time Frame: Baseline (Visit 0) to 12 months ]
    Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.
  • Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work [ Time Frame: Baseline (Visit 0) to 12 months ]
    Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.
  • Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis [ Time Frame: Baseline (Visit 0) to 12 months ]

    The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

  • Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis [ Time Frame: Baseline (Visit 0) to 12 months ]
    BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).
  • Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis [ Time Frame: Baseline (Visit 0) to 12 months ]
    A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.
  • Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis [ Time Frame: Baseline (Visit 0) to 12 months ]
    HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.
  • Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis [ Time Frame: Baseline (Visit 0) to 12 months ]
    The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.
  • Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work [ Time Frame: Baseline (Visit 0) to 12 months ]
    Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months [ Time Frame: 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Predictors of maintained treatment response and/or remission [ Time Frame: 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Change in the frequency of extra-articular manifestations (EAMs) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Duration of Treatment With Adalimumab [ Time Frame: 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Percentage of patients whose co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) could be stopped from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Changes in individual components of Work Productivity and Activity Impairment Specific Health Problem Questionnaire [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis) - (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months
  • Change in the percentage of patients who have paid work from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with AS (Ankylosing Spondylitis)
  • Change in Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (in case of axial symptoms) and/or Disease Activity Score/ 28 joints (DAS28) (in case of peripheral symptoms) from study baseline to 12 months, [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Correlation between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) throughout the observational period of 12 months, [ Time Frame: 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Predictors of maintained treatment response and/or remission, [ Time Frame: 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score (in case of peripheral symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) score (in case of axial symptoms) from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Change in the frequency of extra-articular manifestations (EAMs) from study baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Duration of treatment with adalimumab [ Time Frame: 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Percentage of patients whose co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) could be stopped from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Changes in individual components of Work Productivity and Activity Impairment-Specific Health Problem Questionnaire score (% Presenteeism, % Absenteeism, % Total work productivity impairment, % Total activity impairment) from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
  • Change in the percentage of patients who have paid work from baseline to 12 months [ Time Frame: Day 0 to 12 months ]
    Patients with PsA (Psoriatic Arthritis)
Not Provided
Not Provided
 
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis
This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.
Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
This study is a post-marketing observational study (PMOS) where adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. Study population will consist of adult aged (>18 years) with Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) that can be administered adalimumab as per locally approved Summary of Product Characteristics (SmPC) and reimbursement criteria.
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
Not Provided
  • Ankylosing Spondylitis
    Participants with a diagnosis of ankylosing spondylitis
  • Psoriatic Arthritis
    Participants with a diagnosis of psoriatic arthritis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients will be enrolled in this Postmarketing observational study PMOS if they fulfill all of the below criteria:

  1. Adult patients with diagnosis of Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).
  2. Eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines.
  3. Have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment.
  4. Have negative result of Tuberculosis (TB) screening test or TB prophylaxis as per local guidelines.
  5. Are willing to provide Authorization to the investigator to use and/or disclose personal and/or health data, or to provide Informed Consent if requested by the Local Regulations, before entry into the study.

Exclusion Criteria:

Patients fulfilling below exclusion criteria will not be eligible for this Postmarketing study (PMOS):

1. Meet contraindications for treatment with adalimumab as outlined in the latest version of the local Summary of Product Characteristics (SmPC)

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Czech Republic,   Estonia,   Hungary,   Romania,   Slovakia,   Ukraine
 
NCT01474876
P12-768
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Isidro Villanueva Torrecillas, MD AbbVie
AbbVie
June 2015