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Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

This study has been completed.
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01273519
First received: January 7, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to assess whether or not adalimumab can influence pain medication in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these patients is changed, reduced or stopped due to adalimumab treatment.


Condition
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Changes in patient and physician assessment on present pain severity recorded on a visual analogue scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient and physician assessment on present pain severity recorded on a visual analogue scale [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient and physician assessment on present pain severity recorded on a visual analogue scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient and physician assessment on present pain severity recorded on a visual analogue scale [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient and physician assessment on present pain severity recorded on a visual analogue scale [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient and physician assessment on present pain severity recorded on a Likert Scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient and physician assessment on present pain severity recorded on a Likert Scale [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient and physician assessment on present pain severity recorded on a Likert Scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient and physician assessment on present pain severity recorded on a Likert Scale [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient and physician assessment on present pain severity recorded on a Likert Scale [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient assessment on average pain severity within visit periods recorded on a visual analogue scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient assessment on average pain severity within visit periods recorded on a visual analogue scale [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient assessment on average pain severity within visit periods recorded on a visual analogue scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient assessment on average pain severity within visit periods recorded on a visual analogue scale [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Changes in patient assessment on average pain severity within visit periods recorded on a visual analogue scale [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    When responding to a visual analogue scale item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In this Post Marketing Observational Study a continuous range from 0 to 10 shall be used to measure pain severity

  • Change in patient assessment on average pain severity within visit periods recorded on a Likert scale [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Change in patient assessment on average pain severity within visit periods recorded on a Likert scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Change in patient assessment on average pain severity within visit periods recorded on a Likert scale [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Change in patient assessment on average pain severity within visit periods recorded on a Likert scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient assessment on the pattern of pain progression by descriptive information [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The patient is asked how his/her pattern of pain progression was on average in the past 3 months; daytime, nocturnal, intermittent, continuous, type of beginning suddenly or creeping.

  • Change in patient assessment on average pain severity within visit periods recorded on a Likert scale [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    When responding to a Likert questionnaire item, respondents specify their level of agreement to a statement. Within this Post Marketing Observational Study a 4 point Likert scale shall be used to measure pain intensity (0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain)

  • Changes in patient assessment on the pattern of pain progression by descriptive information [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The patient is asked how his/her pattern of pain progression was on average in the past 3 months; daytime, nocturnal, intermittent, continuous, type of beginning suddenly or creeping.

  • Changes in patient assessment on the pattern of pain progression by descriptive information [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The patient is asked how his/her pattern of pain progression was on average in the past 3 months; daytime, nocturnal, intermittent, continuous, type of beginning suddenly or creeping.

  • Changes in patient assessment on the pattern of pain progression by descriptive information [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The patient is asked how his/her pattern of pain progression was on average in the past 3 months; daytime, nocturnal, intermittent, continuous, type of beginning suddenly or creeping.

  • Changes in patient assessment on the pattern of pain progression by descriptive information [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The patient is asked how his/her pattern of pain progression was on average in the past 3 months; daytime, nocturnal, intermittent, continuous, type of beginning suddenly or creeping.

  • Changes in patient assessment on the presence of nocturnal pain by descriptive information [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The patient is asked how often on average was the presence of nocturnal pain in the past 3 month; never; rarely, every night, more than once a night per week

  • Changes in patient assessment on the presence of nocturnal pain by descriptive information [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The patient is asked how often on average was the presence of nocturnal pain in the past 3 month; never; rarely, every night, more than once a night per week

  • Changes in patient assessment on the presence of nocturnal pain by descriptive information [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The patient is asked how often on average was the presence of nocturnal pain in the past 3 month; never; rarely, every night, more than once a night per week

  • Changes in patient assessment on the presence of nocturnal pain by descriptive information [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The patient is asked how often on average was the presence of nocturnal pain in the past 3 month; never; rarely, every night, more than once a night per week

  • Changes in patient assessment on distress caused by pain recorded on a Likert scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The patient shall indicate his/her perception of average distress caused by pain in the past 3 month; no pain, not-,slightly-,moderately-, greatly distressed by pains

  • Changes in patient assessment on the presence of nocturnal pain by descriptive information [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The patient is asked how often on average was the presence of nocturnal pain in the past 3 month; never; rarely, every night, more than once a night per week

  • Changes in patient assessment on distress caused by pain recorded on a Likert scale [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The patient shall indicate his/her perception of average distress caused by pain in the past 3 month; no pain, not-,slightly-,moderately-, greatly distressed by pains

  • Changes in patient assessment on distress caused by pain recorded on a Likert scale [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The patient shall indicate his/her perception of average distress caused by pain in the past 3 month; no pain, not-,slightly-,moderately-, greatly distressed by pains

  • Changes in patient assessment on distress caused by pain recorded on a Likert scale [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The patient shall indicate his/her perception of average distress caused by pain in the past 3 month; no pain, not-,slightly-,moderately-, greatly distressed by pains

  • Changes in patient assessment on distress caused by pain recorded on a Likert scale [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The patient shall indicate his/her perception of average distress caused by pain in the past 3 month; no pain, not-,slightly-,moderately-, greatly distressed by pains


Secondary Outcome Measures:
  • Medical Outcomes Study Short Form 36 as generic measure of health status for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The Study Short Form 36 is a multi-purpose, short-form health survey with only 36 questions. It is a measuring instrument which can be used for several diseases which captures health related quality of life in patients.

  • Medical Outcomes Study Short Form 36 as generic measure of health status for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The Study Short Form 36 is a multi-purpose, short-form health survey with only 36 questions. It is a measuring instrument which can be used for several diseases which captures health related quality of life in patients.

  • Medical Outcomes Study Short Form 36 as generic measure of health status for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The Study Short Form 36 is a multi-purpose, short-form health survey with only 36 questions. It is a measuring instrument which can be used for several diseases which captures health related quality of life in patients.

  • Medical Outcomes Study Short Form 36 as generic measure of health status for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The Study Short Form 36 is a multi-purpose, short-form health survey with only 36 questions. It is a measuring instrument which can be used for several diseases which captures health related quality of life in patients.

  • Medical Outcomes Study Short Form 36 as generic measure of health status for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The Study Short Form 36 is a multi-purpose, short-form health survey with only 36 questions. It is a measuring instrument which can be used for several diseases which captures health related quality of life in patients.

  • Changes in Health Assessment Questionnaire-Disability Index for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire-Disability Index is a questionnaire that measures functional status (disability) and health-related quality of life.

  • Changes in Health Assessment Questionnaire-Disability Index for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire-Disability Index is a questionnaire that measures functional status (disability) and health-related quality of life.

  • Changes in Health Assessment Questionnaire-Disability Index for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire-Disability Index is a questionnaire that measures functional status (disability) and health-related quality of life.

  • Changes in Health Assessment Questionnaire-Disability Index for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire-Disability Index is a questionnaire that measures functional status (disability) and health-related quality of life.

  • Changes in Health Assessment Questionnaire-Disability Index for rheumatoid arthritis and if reasonable in patients with psoriatic arthritis [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The Health Assessment Questionnaire-Disability Index is a questionnaire that measures functional status (disability) and health-related quality of life.

  • Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  • Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  • Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  • Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  • Changes in Bath Ankylosing Spondylitis Functional Index for ankylosing spondylitis patients [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Functional Index is a set of 10 questions designed to determine the degree of functional limitation in those patients with ankylosing spondylitis.

  • Changes in Bath Ankylosing Spondylitis Functional Index for ankylosing spondylitis patients [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Functional Index is a set of 10 questions designed to determine the degree of functional limitation in those patients with ankylosing spondylitis.

  • Changes in Bath Ankylosing Spondylitis Functional Index for ankylosing spondylitis patients [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Functional Index is a set of 10 questions designed to determine the degree of functional limitation in those patients with ankylosing spondylitis.

  • Changes in Bath Ankylosing Spondylitis Functional Index for ankylosing spondylitis patients [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Functional Index is a set of 10 questions designed to determine the degree of functional limitation in those patients with ankylosing spondylitis.

  • Changes in Bath Ankylosing Spondylitis Functional Index for ankylosing spondylitis patients [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Functional Index is a set of 10 questions designed to determine the degree of functional limitation in those patients with ankylosing spondylitis.

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in patients with ankylosing spondylitis [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in patients with ankylosing spondylitis [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in patients with ankylosing spondylitis [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in patients with ankylosing spondylitis [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  • Erythrocyte Sedimentation Rate [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active rheumatic disease.

  • Changes in Bath Ankylosing Spondylitis Disease Activity Index in patients with ankylosing spondylitis [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The Bath Ankylosing Spondylitis Disease Activity Index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (=enthesitis), duration of morning stiffness, severity of morning stiffness

  • Erythrocyte Sedimentation Rate [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active rheumatic disease.

  • Erythrocyte Sedimentation Rate [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active rheumatic disease.

  • Erythrocyte Sedimentation Rate [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active rheumatic disease.

  • Erythrocyte Sedimentation Rate [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and non active rheumatic disease.

  • C-reactive protein [ Time Frame: at month 3 ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.

  • C-reactive protein [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.

  • C-reactive protein [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.

  • Changes in Rheumatoid Arthritis Disease Activity Index in patients with rheumatoid arthritis and if reasonable in patients with psoriasis arthritis [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The Rheumatoid Arthritis Disease Activity Index is a questionnaire which measures disease activity

  • C-reactive protein [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.

  • C-reactive protein [ Time Frame: at month 9 ] [ Designated as safety issue: No ]
    The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation.


Enrollment: 156
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid-Psoriatic Arthritis, Bechterew
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, unsatisfactory disease modifying antirheumatic drugs response and or biological disease modifying antirheumatic drugs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic and medical practice specialized in rheumatology

Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis

  • Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (Chest X-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:

    • unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
    • unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis.

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics;
  • Patients participating in another study program or clinical trial.
  • Patients who have been treated with Humira® before
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273519

Locations
Austria
Site Reference ID/Investigator# 52144
Bludenz, Austria, 6700
Site Reference ID/Investigator# 44915
Fuerstenfeld, Austria, 8280
Site Reference ID/Investigator# 44910
Gloggnitz, Austria, A-2640
Site Reference ID/Investigator# 44914
Graz, Austria, A-8020
Site Reference ID/Investigator# 52143
Innsbruck, Austria, 6020
Site Reference ID/Investigator# 44916
Klagenfurt, Austria, A-9020
Site Reference ID/Investigator# 44913
Linz, Austria, A-4020
Site Reference ID/Investigator# 44911
Linz, Austria, 4030
Site Reference ID/Investigator# 44912
Linz, Austria, A-4020
Site Reference ID/Investigator# 44906
Neudorf, Austria, A-2351
Site Reference ID/Investigator# 52145
Spitz, Austria, 3620
Site Reference ID/Investigator# 44909
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 44908
Stockerau, Austria, 2000
Site Reference ID/Investigator# 67062
Vienna, Austria, 1040
Site Reference ID/Investigator# 57304
Voecklabruck, Austria, A-4840
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01273519     History of Changes
Other Study ID Numbers: P12-585
Study First Received: January 7, 2011
Last Updated: January 22, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
Ankylosing
Rheumatoid
Antibodies
Arthritis
Pain
 Antirheumatic Agents
Psoriatic
Spondylitis
Monoclonals

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
 Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013