Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Adalimumab (HUMIRA) in Patients With Moderate to Severe Psoriasis in Spain (PROMISE)

This study has been completed.
Sponsor:
Collaborator:
IMS Health
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01076192
First received: February 24, 2010
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of adalimumab (HUMIRA) as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.


Condition
Chronic Plaque Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-authorization, Observational Study to Assess the Effectiveness of Adalimumab (HUMIRA) in Moderate to Severe Psoriasis in Current Clinical Practice in Spain

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Collected every 3 months the first year and every 6 months the second year ] [ Designated as safety issue: No ]
  • Change from baseline in Physician's Global Assessment (PGA) [ Time Frame: Collected every 3 months the first year and every 6 months the second year ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment Questionnaire:Specific Health Problem (WPAI-SHP) and EuroQol (EQ-5D) Quality of life Questionnaire [ Time Frame: Collected every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events of Special Interest and Serious Adverse Events [ Time Frame: Collected as the events occur and are reported during the registry ] [ Designated as safety issue: Yes ]

Enrollment: 548
Study Start Date: February 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Psoriasis receiving adalimumab

Detailed Description:

PROMISE is a 2 year post-authorization study of patients taking HUMIRA for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA. No study specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

  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

Dermatology clinic

Criteria

Inclusion Criteria:

  • Patient with diagnosis of moderate to severe chronic plaque psoriasis newly initiated on adalimumab (Humira) therapy according to the local product labeling,
  • Patient capable of and willing to give written informed consent

Exclusion Criteria:

  • Patients who cannot be treated in accordance with the local product label
  • Patient participating or going to participate in a clinical trial during the study follow-up
  • Patient with difficulties for adequately reading, understanding and completing a questionnaire
  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: NCT01076192

  Show 59 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
IMS Health
Investigators
Study Director: Cristina Sancho Sanchez, PharmD Abbvie Farmaceutica, S.L.U. Spain
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01076192     History of Changes
Other Study ID Numbers: P11-067
Study First Received: February 24, 2010
Last Updated: November 14, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AbbVie:
Moderate Psoriasis
Psoriasis
Severe Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014