Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) (DOSE)
This study has been terminated.
(In Amendment 1 of P05319 [NCT 00779675], the option to enroll into this study, was discontinued due to low numbers of participants with suboptimal response.)
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00833053
First received: January 29, 2009
Last updated: June 19, 2012
Last verified: May 2012
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Purpose
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Infliximab Drug: Infliximab and methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Secondary Outcome Measures:
- Number of Participants With A PASI-50 Response at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.
- Number of Participants With A PASI-90 Response at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.
- Number of Participants With A PASI-100 Response at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.
- Change From Baseline in Mean Participant Raw PASI Scores at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.
- Dermatology Life Quality Index (DLQI) at Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.
- Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
| Enrollment: | 39 |
| Study Start Date: | October 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IFX q 6 weeks |
Drug: Infliximab
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
Other Names:
|
| Experimental: IFX + MTX |
Drug: Infliximab and methotrexate
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319.
- Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
- Subjects must be at least 18 years old
- Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
- Subjects must not be pregnant and must meet contraceptive requirements
- Subjects must meet tuberculosis screening criteria
- Subjects must meet laboratory and medical history screening requirements
Exclusion Criteria:
- Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
- Subjects already using certain investigational, biological, or immunosuppressive drugs
- Subjects with certain comorbid conditions
- Subjects who currently have or have a history of certain infections
- Subjects who have recently received live virus or bacterial vaccinations
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00833053 History of Changes |
| Other Study ID Numbers: | P05315, EUDRACT: 2008-000454-12 |
| Study First Received: | January 29, 2009 |
| Results First Received: | March 15, 2012 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Methotrexate Infliximab 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 Gastrointestinal Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013