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An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Moderate to Severe Plaque Psoriasis

Intervention: Adalimumab (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Martin Okun, MD, Study Director, Affiliation: AbbVie

Summary

This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.

Clinical Details

Official title: An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab (Humira®) in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24

Secondary outcome:

Percentage of Participants Achieving a Physician's Global Assessment of Clear

Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal

Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)

Percentage of Participants Achieving a PASI 50 Response

Percentage of Participants Achieving a PASI 75 Response

Percentage of Participants Achieving a PASI 90 Response

Percentage of Participants Achieving a PASI 100 Response

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

Percent Change From Baseline in Dermatology Life Quality Index (DLQI)

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

Detailed description: During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: A patient will be eligible for study participation if he/she meets the following criteria: 1. Male and female patients ≥ 18 years of age. 2. Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator. 3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history. 4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit. 5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit. Exclusion Criteria: 1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis. 2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis. 3. Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:

- Shampoos that contain no corticosteroid;

- Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment)

emollients;

- Low potency topical corticosteroids on the palms, soles, face, inframammary

area, and groin only. 4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study. 5. Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.

Locations and Contacts

Site Reference ID/Investigator# 67547, Ekaterinburg 620076, Russian Federation

Site Reference ID/Investigator# 78433, Kazan 420012, Russian Federation

Site Reference ID/Investigator# 67542, Moscow 107076, Russian Federation

Site Reference ID/Investigator# 67546, Saratov 410028, Russian Federation

Site Reference ID/Investigator# 78417, Smolensk 214018, Russian Federation

Site Reference ID/Investigator# 67545, St. Petersburg 194044, Russian Federation

Site Reference ID/Investigator# 78413, St. Petersburg 190013, Russian Federation

Additional Information

Starting date: May 2012
Last updated: September 22, 2014

Page last updated: August 23, 2015

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