Efficacy and Safety of Humira in Patients With Psoriatic Arthritis in Normal Medical Practice - Full Text View

Purpose

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

Condition	Intervention
Psoriatic Arthritis	Biological: adalimumab (Humira)

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:

Genetics Home Reference related topics: psoriatic arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

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 ]

Estimated Enrollment:	5000
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with psoriatic arthritis Patients with psoriatic arthritis	Biological: adalimumab (Humira) 40 mg adalimumab (Humira) every other week

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111240

Show 511 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:

Related Info This link exits the ClinicalTrials.gov site

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:	April 26, 2013
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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013