Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01111240
First received: February 26, 2010
Last updated: December 29, 2014
Last verified: December 2014
  Purpose

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.


Condition
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Long Term Documentation to Demonstrate Long Term Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis Under Conditions of Daily Practice

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean Change From Baseline in Disease Activity Score (DAS)28 [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    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 greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

  • Mean Tender Joint Count (TJC) Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.

  • Mean Swollen Joint Count (SJC) Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.

  • Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA.

  • Mean Target Lesion Score (TLS) Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.


Secondary Outcome Measures:
  • Number of Participants by Severity of Enthesitis Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

  • Number of Participants by Severity of Dactylitis Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

  • Number of Participants by Severity of Nail Psoriasis Levels Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.

  • Mean Erythrocyte Sedimentation Rate (ESR) Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The Erythrocyte Sedimentation Rate (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 nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.

  • Mean C-Reactive Protein (CRP) Levels Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The C-Reactive Protein (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. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.

  • Patients Global Assessment of Disease Activity Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

  • Participants Assessment of Fatigue Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

  • Participants Assessment of Pain Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.

  • Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.

  • Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Mean Number of Days Missed From Work Due to Psoriatic Arthritis [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).

  • Percentage of Participants With In-Patient Hospitalization [ Time Frame: Baseline, and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).

  • Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication [ Time Frame: Baseline, and Months 6 and 24 ] [ Designated as safety issue: No ]
    Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs


Enrollment: 4635
Study Start Date: August 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriatic Arthritis
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

Detailed Description:

Psoriatic Arthritis participants receiving adalimumab are evaluated in a prospective, non-interventional study (NIS) for 2 years. Patients receive adalimumab 40 mg every other week (eow), per its label. Efficacy and safety parameters are measured routinely at baseline and after 3, 6, 9, 12, 18 and 24 months.

  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

Clinical routine patients with psoriatic arthritis

Criteria

Inclusion:

  • 18 years of age or older (younger patients may be enrolled at the discretion of physician)
  • Diagnosis of Psoriatic Arthritis (or any indication at the discretion of physician) and initiating adalimumab therapy
  • Signed/dated Informed Consent

Exclusion:

-None

  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: NCT01111240

  Show 509 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD Abbvie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01111240     History of Changes
Other Study ID Numbers: HUM 05-3
Study First Received: February 26, 2010
Results First Received: December 9, 2014
Last Updated: December 29, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Humira
Long-term safety and effectiveness
Psoriatic Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on May 21, 2015