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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2008-000454-12 |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFX q 6 weeks | Experimental |
| |
| IFX + MTX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | 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. | Baseline, Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With A PASI-50 Response at Week 28 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Of the 39 participants that were randomized to the study, 3 (2 Infliximab [IFX] q 6 weeks; and 1 IFX + Methotrexate [MTX]) participants did not meet protocol eligibility criteria and were excluded from the efficacy analysis.
Multicenter: 48 centers in Australia, Belgium, Colombia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, and Russia.
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| ID | Title | Description |
|---|---|---|
| FG000 | IFX q 6 Weeks | Infliximab 5 mg/kg administered every 6 weeks. |
| FG001 | IFX q 8 Weeks + MTX | Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IFX q 6 Weeks | Infliximab 5 mg/kg administered every 6 weeks. |
| BG001 | IFX q 8 Weeks + MTX | Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | 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. | Posted | Number | Participants | Baseline, Week 28 |
|
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Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IFX q 6 Weeks | Infliximab 5 mg/kg administered every 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis Aggravated | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | clinicaltrialsdisclosure@merck.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Infliximab and methotrexate | Drug | Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly) |
|
|
| Baseline, Week 28 |
| Number of Participants With A PASI-90 Response at Week 28 | 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. | Baseline, Week 28 |
| Number of Participants With A PASI-100 Response at Week 28 | 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. | Baseline, Week 28 |
| Change From Baseline in Mean Participant Raw PASI Scores at Week 28 | 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. | Baseline, Week 28 |
| Dermatology Life Quality Index (DLQI) at Week 28 | 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. | Week 28 |
| Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28 | 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. | Baseline, Week 28 |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With A PASI-50 Response at Week 28 | 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. | The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Baseline, Week 28 |
|
|
| Secondary | Number of Participants With A PASI-90 Response at Week 28 | 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. | The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Baseline, Week 28 |
|
|
| Secondary | Number of Participants With A PASI-100 Response at Week 28 | 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. | The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Baseline, Week 28 |
|
|
| Secondary | Change From Baseline in Mean Participant Raw PASI Scores at Week 28 | 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 study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Baseline, Week 28 |
|
|
| Secondary | Dermatology Life Quality Index (DLQI) at Week 28 | 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. | The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Week 28 |
|
|
| Secondary | Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28 | 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. | The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population. | Posted | Baseline, Week 28 |
|
|
| 1 |
| 18 |
| 8 |
| 18 |
| EG001 | IFX q 8 Weeks + MTX | Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly. | 0 | 19 | 6 | 19 |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA (10.0) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) |
|
| Chest Discomfort | General disorders | MedDRA (10.0) |
|
| Infusion Related Reaction | General disorders | MedDRA (10.0) |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) |
|
| Oral Herpes | Infections and infestations | MedDRA (10.0) |
|
| Rash Pustular | Infections and infestations | MedDRA (10.0) |
|
| Renal Abscess | Infections and infestations | MedDRA (10.0) |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (10.0) |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) |
|
| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA (10.0) |
|
| Blood Pressure Increased | Investigations | MedDRA (10.0) |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (10.0) |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
|
| Hypotonia | Nervous system disorders | MedDRA (10.0) |
|
| Vaginal Inflammation | Reproductive system and breast disorders | MedDRA (10.0) |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |