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Documentation of Humira in Psoriasis Patients in Routine Clinical Practice (LOTOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077232
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Condition or disease
Moderate to Severe Plaque Psoriasis

Detailed Description:

Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:

  • the number of missed working days
  • the number of visits to doctor's office
  • the number and duration of hospitalizations
  • work ability to assess efficacy for different subgroups by
  • the number of patients achieving a PASI 75 response to evaluate safety by
  • the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease

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Study Type : Observational
Actual Enrollment : 5442 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)
Actual Study Start Date : January 4, 2008
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Psoriasis Patients
Patients with moderate to severe plaque psoriasis



Primary Outcome Measures :
  1. Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction. [ Time Frame: At 24, 48 and 60 months ]
  2. Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability. [ Time Frame: At 24, 48 and 60 months ]
  3. Safety and tolerability assessed by analyzing serious and non-serous adverse events. [ Time Frame: At 24, 48 and 60 months ]

Secondary Outcome Measures :
  1. Global physician's assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]
  2. Target Nail Psoriasis Severity Index (target NAPSI). [ Time Frame: At 24 months ]
  3. Itch Visual Analogue Scale (Itch VAS). [ Time Frame: At 24 months ]
  4. Safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication. [ Time Frame: At 24, 48 and 60 months ]
  5. Palmoplantar Psoriasis Area Severity Index (pPASI). [ Time Frame: At 24 months ]
  6. Influence of body mass index and weight on efficacy measurement. [ Time Frame: At 24, 48 and 60 months ]
  7. Patients' assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample: Patients with Plaque Psoriasis
Criteria

Inclusion Criteria:

- Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077232


Locations
Show Show 641 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01077232    
Other Study ID Numbers: P10-446
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Moderate to Severe Plaque Psoriasis
Humira
Safety
Efficacy
Work Productivity
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases