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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01078610
Other study ID # P12-023
Secondary ID
Status Withdrawn
Phase N/A
First received February 26, 2010
Last updated August 8, 2012

Study information

Verified date June 2012
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial Summary

Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.


Description:

The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):

- The number of missed working days

- The self-assessed workability

- The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)

- The severity of functional impairment (Health Assessment Questionnaire)

- The health-related quality of life .

All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.

The secondary objective is to document the therapeutic success by the following variables:

- The number of physician visit

- The number and duration of hospitalization

- The number of days of impairment in non-occupational activities

- Pain, exhaustion/fatigue

- The reduction of number and dose of concomitant medication

- Patient's assessment of adalimumab therapy compared to previous therapies.

Target parameters for safety evaluation of adalimumab are:

- The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)

- Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
adalimumab (Humira)
40 mg adalimumab (Humira) every other week.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events Months 0, 3, 6, 12, 24, 36, 48, 60 Yes
Secondary Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies. Months 0, 3, 6, 12, 24, 36, 48, 60 Yes
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