Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
Abbott (Peru)
Information provided by (Responsible Party):
AbbVie ( Abbott (Peru) )
ClinicalTrials.gov Identifier:
NCT01156532
First received: July 1, 2010
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
Recently, adalimumab has been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness; and impact in the health related quality of life with the use of Adalimumab in psoriatic patients complying with the dosing and monitoring recommendations of the local approved label.
| Condition |
|---|
|
Moderate to Severe Psoriasis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Proportion of patients reaching a Psoriasis Area and Severity Index score of 75 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Patients reaching a minimal important difference (MID) Dermatology Life Quality Index score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Important difference (MID) Dermatology Life Quality Index score between 2.3-5
Secondary Outcome Measures:
- Proportion of patients reaching a Euro Quality of Life -5 Dimensions index score increasing (improvement) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Mean increasing of at least 0.2
- Serious Adverse Events [ Time Frame: Since enrollment until 70 days after the last study adalimumab dose ] [ Designated as safety issue: Yes ]Serious adverse events; including occurrence of Tuberculosis, opportunistic infection and cancer
- Adherence of adalimumab treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Participants whose percentages of missed dose are < 20%, are considered as "compliant"
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Psoriatic patients with adalimumab treatment
Participant with moderate to severe chronic plaque Psoriasis defined as Psoriasis Area and Severity Index ≥ 10 and Body surface area ≥ 10% with or without psoriatic arthritis, who have adalimumab therapy indication because are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
|
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
Patients with moderate to severe psoriasis who receive adalimumab therapy according to habitual clinical practice, at Peruvian hospitals/clinics
Criteria
Inclusion Criteria:
- Participants ≥ 18 years old
- Participant moderate to severe chronic plaque Psoriasis defined as Psoriasis Area and Severity Index ≥ 10 and Body surface area ≥ 10% with or without psoriatic arthritis, who have adalimumab therapy indication because are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
- Patient is capable of and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria:
- Participants should not be enrolled if they cannot be treated in accordance with the local product label
- Participants enrolled into another study or clinical trial
- History of Hepatitis B infection
- History of neurologic symptoms suggestive of central nervous system demyelinating disease
- History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
- Active Tuberculosis infection before initiating adalimumab treatment or latent Tuberculosis infection not able to take complete prophylactic treatment
- Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
- Use of another anti- Tumoral Necrosis Factor previously
- History of Congestive Heart Failure
- Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects patients to an unacceptable risk
- Participants with active infection including chronic or localized infections until infections are controlled
- History of sensitive to latex
- Participants who will receive concomitant phototherapy and systemic therapy during Humira therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156532
Contacts
| Contact: Oscar E Guerra, MD | 51-1 2193300-3311 | oscar.guerra@abbott.com |
| Contact: Javier D Marquez, MD | 51-1 2193300-3308 | javier.d.iglesias@abbott.com |
Locations
| Peru | |
| Site Reference ID/Investigator# 35783 | Recruiting |
| Lima, Peru | |
| Principal Investigator: Site Reference ID/Investigator# 35783 | |
| Site Reference ID/Investigator# 56700 | Recruiting |
| Lima, Peru | |
| Principal Investigator: Site Reference ID/Investigator# 56700 | |
| Site Reference ID/Investigator# 43147 | Recruiting |
| Trujillo, Peru | |
| Principal Investigator: Site Reference ID/Investigator# 43147 | |
Sponsors and Collaborators
Abbott (Peru)
Investigators
| Study Director: | Oscar E Guerra, MD | Abbott |
More Information
No publications provided
| Responsible Party: | AbbVie ( Abbott (Peru) ) |
| ClinicalTrials.gov Identifier: | NCT01156532 History of Changes |
| Other Study ID Numbers: | P12-261 |
| Study First Received: | July 1, 2010 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Peru: Ethics Committee |
Keywords provided by AbbVie:
|
adalimumab therapy Psoriasis observational study |
Additional relevant MeSH terms:
|
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