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: January 17, 2014
Last verified: January 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:
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Effectiveness: DAS28 (Disease Activity Score), Target Lesion Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Effectiveness: nail involvement of hands [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Effectiveness: improvement of dactylitis and enthesitis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety: side effects [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Safety: side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Safety: side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety: side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Safety: side effects [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Safety: side effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 4626
Study Start Date: July 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with psoriatic arthritis
Patients with psoriatic arthritis

Detailed Description:

PsA patients 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, 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 Criteria:

  • Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy

Exclusion Criteria:

  • Hypersensitivity against the drug or one of the other ingredients
  • active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
  • moderate to severe cardiac insufficiency
  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 512 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stefan Simianer, 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
Last Updated: January 17, 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
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014