A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00679731
First received: May 15, 2008
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.


Condition Intervention Phase
Psoriasis
Drug: ABT-874
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Changes from Baseline in the DLQI total score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Changes from Baseline in the DLQI total score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 317
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ABT-874
Drug: ABT-874
200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection
Active Comparator: B
Methotrexate
Drug: Methotrexate
5.0 to 25 mg weekly

Detailed Description:

This study is only being conducted in the EU and Canada

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Psoriasis for 6 MO.. BSA 10%, PASI 12 or above, PGA 3 or above

Exclusion Criteria:

  • Previous exposure to anti-IL 12
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679731

  Show 43 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Martin Kaul, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00679731     History of Changes
Other Study ID Numbers: M10-255, 2007-004687-47
Study First Received: May 15, 2008
Last Updated: January 22, 2013
Health Authority: European Union: European Medicines Agency
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency
Finland: Finnish Medicines Agency
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
Greece: Ministry of Health and Welfare
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AbbVie:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014