Psoriasis Clinical Trial
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
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | November 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Site Reference ID/Investigator# 9904 | Graz | |
| Austria | Site Reference ID/Investigator# 11001 | Vienna | |
| Austria | Site Reference ID/Investigator# 12763 | Vienna | |
| Belgium | Site Reference ID/Investigator# 8022 | Brussels | |
| Canada | Site Reference ID/Investigator# 13104 | Barrie | |
| Canada | Site Reference ID/Investigator# 13161 | Halifax | |
| Canada | Site Reference ID/Investigator# 11864 | Hamilton | |
| Canada | Site Reference ID/Investigator# 13223 | Quebec City | |
| Canada | Site Reference ID/Investigator# 13221 | Waterloo | |
| Denmark | Site Reference ID/Investigator# 11381 | Aarhus | |
| Denmark | Site Reference ID/Investigator# 11841 | Copenhagen NV | |
| Finland | Site Reference ID/Investigator# 8030 | Helsinki | |
| Finland | Site Reference ID/Investigator# 8033 | Kuopio | |
| Finland | Site Reference ID/Investigator# 8021 | Lahti | |
| Finland | Site Reference ID/Investigator# 8026 | Turku | |
| France | Site Reference ID/Investigator# 11661 | Creteil | |
| France | Site Reference ID/Investigator# 11504 | Nice | |
| France | Site Reference ID/Investigator# 11161 | Paris | |
| France | Site Reference ID/Investigator# 10963 | Toulouse Cedex 9 | |
| Germany | Site Reference ID/Investigator# 8025 | Berlin | |
| Germany | Site Reference ID/Investigator# 8024 | Frankfurt am Main | |
| Germany | Site Reference ID/Investigator# 8032 | Hamburg | |
| Germany | Site Reference ID/Investigator# 8027 | Kiel | |
| Germany | Site Reference ID/Investigator# 8019 | Muenster | |
| Germany | Site Reference ID/Investigator# 8035 | Munich | |
| Germany | Site Reference ID/Investigator# 8023 | Tuebingen | |
| Greece | Site Reference ID/Investigator# 13422 | Athens | |
| Greece | Site Reference ID/Investigator# 13462 | Athens | |
| Greece | Site Reference ID/Investigator# 13461 | Thessaloniki | |
| Italy | Site Reference ID/Investigator# 12381 | Milan | |
| Italy | Site Reference ID/Investigator# 9583 | Modena | |
| Italy | Site Reference ID/Investigator# 8551 | Rome | |
| Netherlands | Site Reference ID/Investigator# 11701 | Amsterdam | |
| Netherlands | Site Reference ID/Investigator# 8363 | Nijmegen | |
| Spain | Site Reference ID/Investigator# 13481 | Barcelona | |
| Spain | Site Reference ID/Investigator# 10702 | Madrid | |
| Spain | Site Reference ID/Investigator# 13163 | Seville | |
| Spain | Site Reference ID/Investigator# 8362 | Valencia | |
| Sweden | Site Reference ID/Investigator# 8185 | Stockholm | |
| Switzerland | Site Reference ID/Investigator# 10203 | Geneva 14 | |
| Switzerland | Site Reference ID/Investigator# 8020 | Zurich | |
| United Kingdom | Site Reference ID/Investigator# 12401 | Aberdeen | |
| United Kingdom | Site Reference ID/Investigator# 8034 | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 | Week 24 | No | |
| Primary | The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 | Week 24 | No | |
| Primary | Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 | Week 52 | No | |
| Primary | The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 | Week 52 | No | |
| Secondary | Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24 | Week 24 | No | |
| Secondary | Changes from Baseline in the DLQI total score at Week 24 | Week 24 | No | |
| Secondary | Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52 | Week 52 | No | |
| Secondary | Changes from Baseline in the DLQI total score at Week 52 | Week 52 | No |
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