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

NCT01644396 | Completed Phase 4 Results

• 1 other identifier: M13-279
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

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

  The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

  Baseline and Week 24

Secondary Outcomes (10)

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

  Weeks 2, 4, 8, 12, 16 and 24

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

  Weeks 2, 4, 8, 12, 16 and 24

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

  Baseline and Weeks 2, 4, 8, 12, 16 and 24

• Percentage of Participants Achieving a PASI 50 Response

  Baseline and Weeks 2, 4, 8, 12, 16, and 24

• Percentage of Participants Achieving a PASI 75 Response

  Baseline and Weeks 2, 4, 8, 12, and 16

Other Outcomes (28)

• Change From Baseline in Hemoglobin

  Baseline and Week 24 (or Early Termination Visit)

• Change From Baseline in Hematocrit

  Baseline and Week 24 (or Early Termination Visit)

• Change From Baseline in Red Blood Cell Count

  Baseline and Week 24 (or Early Termination Visit)

Study Arms (1)

Adalimumab

OTHER

Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Also known as: ABT-D2E7, Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient will be eligible for study participation if he/she meets the following criteria:
• Male and female patients ≥ 18 years of age.
• 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.
• Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
• Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
• PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

You may not qualify if:

• Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
• Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
• 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.
• Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (7)

Site Reference ID/Investigator# 78433

Kazan', 420012, Russia

Location

Site Reference ID/Investigator# 67542

Moscow, 107076, Russia

Location

Site Reference ID/Investigator# 78413

Saint Petersburg, 190013, Russia

Location

Site Reference ID/Investigator# 67545

Saint Petersburg, 194044, Russia

Location

Site Reference ID/Investigator# 67546

Saratov, 410028, Russia

Location

Site Reference ID/Investigator# 78417

Smolensk, 214018, Russia

Location

Site Reference ID/Investigator# 67547

Yekaterinburg, 620076, Russia

Location

Related Links

• Related Info

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Martin Okun, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: July 19, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 1, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

RU (7)