Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 28 of 33 for:    ACITRETIN

Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075697
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Spanish Agency of Medicines and Health Products
Janssen, LP
Merck Sharp & Dohme Corp.
Pfizer
Abbott
Eli Lilly and Company
Novartis
Information provided by (Responsible Party):
Fundación Academia Española de Dermatología

Tracking Information
First Submitted Date January 3, 2013
First Posted Date March 3, 2014
Last Update Posted Date October 9, 2019
Study Start Date October 2008
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2014)
Serious Adverse Events [ Time Frame: an expected mean follow-up of 5 years ]
Lag windows used to link events and therapy are described in the study web site.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02075697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 28, 2014)
Other adverse events leading to changes in drug therapy or unexpected visits to health provider [ Time Frame: an expected mean follow-up of 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2014)
Mortality [ Time Frame: an expected mean follow-up of 5 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Spanish Registry of Systemic Treatments in Psoriasis
Official Title Spanish Registry of Systemic Treatments in Psoriasis
Brief Summary The purpose of Biobadaderm is a to study the safety of systemic therapy in psoriasis.
Detailed Description

The Spanish Registry for Adverse Events of Biological Therapies in Dermatology (BIOBADADERM) was launched in October 2008, as a pharmacovigilance effort for psoriatic patients. The registry is managed by the Foundation of the Spanish Academy of Dermatology and Venereology (AEDV). BIOBADADERM has been promoted by the AEDV, in collaboration with the Spanish Agency for Medicines and Health Products (AEMPS) and the Research Unit of the Spanish Foundation of Rheumatology (FER) and the Research Unit of the Fundacion AEDV. BIOBADADERM is part of PSONET, a European network for sharing data from records of patients treated with biologics.

BIOBADADERM is a prospective cohort of patients receiving biologic drugs that can be compared with another cohort of patients receiving other systemic treatments. One of the cohorts is made up of all consecutive psoriasis patients who begin any biological therapy (including infliximab (INF), etanercept (ET), efalizumab (EFA), adalimumab (ADA), rituximab (RTX) and ustekinumab (UTK)) in each centre. The control cohort consists of psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (methotrexate, cyclosporine or acitretin).

The objectives of BIOBADADERM are:

  • Identify adverse events (AEs) occurring during the relevant treatment with biologic therapies, and estimate their frequency;
  • Identify unexpected AEs, particularly those that may occur after long periods of exposure;
  • Identify relevant AEs that arise after discontinuation of treatment;
  • Estimate the relative risk of developing AEs with biologic therapies in patients with psoriasis compared to psoriatic patients exposed to other systemic (non-biological); and
  • Identify risk factors for AEs in patients with these treatments.

Data were initially collected retrospectively in hospitals with a list of all patients who had received biologic drugs between 1 January 2005 and 30 October 2008 and check-ups with a frequency of at least every 6 months. Since 2008, data have been captured prospectively.

The database includes demographic, diagnostic and comorbidity data, the treatments performed, the duration of these treatments and the adverse effects that arise (coded using MedDRA). In its first year, 632 patients from 12 centers participated with BIOBADADERM. In October 2012 the registry had data from 1,793 patients, which includes 946 patients on biologic treatments and 847 patients on non-biologic systemic treatments.

Data for each patient have been reversibly anonymized and entered into a database. Data are entered over the Internet (http://biobadaser.ser.es/biobadaderm/). The data are stored in the Research Department of the Spanish Rheumatology Foundation.

The included data are continually revised online by a study monitor to verify consistency, comprehensiveness, and absence of anomalies. A follow-up visit is made every year during which a sample of the the data in the database are compared with those in the clinical records.

Sample size was calculated to give, after 5 years, 80% power and using alfa level= 0.05, to detect a rate ratio of 2 in events with 4.1 cases per 1000 person-years, or a rate ratio of 5 in events with 0.5 cases per 1000 person-years. Further calculations are available in the study protocol (https://biobadaser.ser.es/biobadaderm/index.html).

Default value in each variable is "missing". Plans for missing data in analysis depend on the aim of analysis but with a preference for the most conservative ( in terms of patient safety) analysis.

Analysis consists of description of rates, rate ratios and adjusted rate ratios (adjusted for possible confounders, age always included).

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Psoriasis patients requiring systemic therapy.
Condition Psoriasis
Intervention Not Provided
Study Groups/Cohorts
  • New drugs
    Cohort exposed to biologic therapy, apremilast or fumarates
  • Classic systemic therapy
    Non-biological systemic treatment (methotrexate, cyclosporine and acitretin) Phototherapy was accepted as systemic therapy only in the small group of patients retrospectively included(PUVA, UVB 311).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 8, 2019)
3500
Original Estimated Enrollment
 (submitted: February 28, 2014)
1887
Estimated Study Completion Date October 2025
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • For biologics group: all consecutive psoriasis patients who begin any biological therapy
  • For classic systemic group: the next psoriasis patients who begin, for the first time, a nonbiologic systemic treatment (after including a patient in the biologics group)

Exclusion Criteria:

  • Intention of moving to a different geographic area in the next three months
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ignacio Garcia-Doval, PhD, MScEpid 34- 915446284 investigacion@aedv.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02075697
Other Study ID Numbers Biobadaderm
Biobadaderm ( Registry Identifier: Biobadaderm )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundación Academia Española de Dermatología
Study Sponsor Fundación Academia Española de Dermatología
Collaborators
  • Spanish Agency of Medicines and Health Products
  • Janssen, LP
  • Merck Sharp & Dohme Corp.
  • Pfizer
  • Abbott
  • Eli Lilly and Company
  • Novartis
Investigators
Principal Investigator: Esteban Daudén, PhD Hospital de La Princesa- Madrid
PRS Account Fundación Academia Española de Dermatología
Verification Date October 2019