Last reviewed · How we verify
The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)
Phase 3 trial testing infliximab in Psoriasis in 868 participants. Completed in 1 June 2008.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 868 |
| Start date | 1 September 2005 |
| Primary completion | 1 June 2008 |
| Estimated completion | 1 June 2008 |
Merck Sharp & Dohme LLC — full company profile →
Adults 18 to 75, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Infliximab | 0.78 | |
| Methotrexate | 0.42 |
PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Infliximab | 0.77 | |
| Methotrexate | 0.31 |
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
| Group | Value | 95% CI |
|---|---|---|
| Infliximab | 0.76 | |
| Methotrexate | 0.38 |
PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
| Group | Value | 95% CI |
|---|---|---|
| Infliximab | 0.73 | |
| Methotrexate | 0.28 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Infliximab | Methotrexate | Participants Who Switched … | Participants Who Switched … |
|---|---|---|---|---|---|
| INFUSION RELATED REACTION | General disorders | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — | — | — | — |
| CHOLECYSTITIS | Hepatobiliary disorders | — | — | — | — |
| HYPERSENSITIVITY | Immune system disorders | — | — | — | — |
| PNEUMONIA | Infections and infestations | — | — | — | — |
| HEPATIC ENZYME INCREASED | Investigations | — | — | — | — |
| PSORIASIS | Skin and subcutaneous tissue disorders | — | — | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — | — | — |
| ANGINA PECTORIS | Cardiac disorders | — | — | — | — |
| MYOCARDIAL INFARCTION | Cardiac disorders | — | — | — | — |
| PERICARDITIS | Cardiac disorders | — | — | — | — |
| PHIMOSIS | Congenital, familial and genetic disorders | — | — | — | — |
| IRIDOCYCLITIS | Eye disorders | — | — | — | — |
| MACULAR HOLE | Eye disorders | — | — | — | — |
| GASTRITIS | Gastrointestinal disorders | — | — | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — | — | — |
| PYREXIA | General disorders | — | — | — | — |
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | — | — | — | — |
| BILIARY COLIC | Hepatobiliary disorders | — | — | — | — |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | — | — | — | — |
| CHOLELITHIASIS | Hepatobiliary disorders | — | — | — | — |
| TYPE IV HYPERSENSITIVITY REACTION | Immune system disorders | — | — | — | — |
| ARTHRITIS BACTERIAL | Infections and infestations | — | — | — | — |
| FEBRILE INFECTION | Infections and infestations | — | — | — | — |
| Reaction | System | Infliximab | Methotrexate | Participants Who Switched … | Participants Who Switched … |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | — | — | — | — |
| INFUSION RELATED REACTION | General disorders | — | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — | — | — | — |
| FATIGUE | General disorders | — | — | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — | — |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | — | — | — | — |
| EPIDIDYMITIS | Reproductive system and breast disorders | — | — | — | — |
Most-reported serious reactions: INFUSION RELATED REACTION, ARTHRALGIA, ATRIAL FIBRILLATION, CHOLECYSTITIS, HYPERSENSITIVITY, PNEUMONIA, HEPATIC ENZYME INCREASED, PSORIASIS.
Data from ClinicalTrials.gov NCT00251641 adverse events section.
This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).
6 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00251641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing