Phase 4
Completed N=489
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT01059773 ↗Enrolled (actual)
489
Serious AEs
8.2%
Results posted
Jan 2012
Primary outcomePrimary: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 — 149; 158 participants
Summary
This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 |
149; 158 | — |
| SECONDARY Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period |
116; 33; 124; 34; 127; 35 | — |
| SECONDARY Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period |
11; 2; 5; 0; 11; 3 | — |
| SECONDARY Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period |
36; 13; 42; 11; 43; 14 | — |
| SECONDARY Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline |
-3.73; -4.28; -7.65; -7.82; -12.93; -12.7 | — |
| SECONDARY Proportion of Patients Achieving PASI 50 Response |
10.3; 15.6; 39.3; 49.2; 83.8; 86.1 | — |
| SECONDARY Proportion of Patients Achieving PASI 75 Response |
2.9; 2.5; 12.0; 15.3; 58.1; 62.2 | — |
| SECONDARY Proportion of Patients Achieving PASI 90 Response |
0.4; 0.8; 3.3; 3.3; 33.2; 31.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should have diagnosis of plaque-type psoriasis for at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)
- Moderate-to-severe psoriasis scored as PASI >= 10 at screening and at the time of first administration of ustekinumab
- Should currently receive (and have been receiving for at least 8 weeks directly prior to screening) systemic therapy with methotrexate at a dose of at least 10 mg/week but not exceeding 25 mg/week, with an inadequate response to this treatment (due to either efficacy or tolerability) and, in the judgment of the treating physician and patient, a treatment change is needed
- Women should take adequate birth control measures throughout the study and must agree to continue to use such birth control measures and not to become pregnant or plan to become pregnant for at least 15 weeks after the last dose of ustekinumab and for at least 6 months after the last dose of methotrexate
- Men must be using adequate birth control measures whilst receiving methotrexate and for 6 months after the last dose of methotrexate
Exclusion Criteria
- Patients should not have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
- Should currently (and within 12 months) not receive ciclosporin, fumarates, PUVA, etanercept, efalizumab, infliximab, adalimumab or alefacept or other biologic or systemic therapy (and other therapy as indicated in the protocol)
- Women who are pregnant, breastfeeding, or planning pregnancy (both men and women) while enrolled in the study
- Have previously failed treatment with any therapeutic agent directly targeted at reducing IL-12 or IL-23, including, but not limited to, ustekinumab and ABT-874
- Active or latent Tuberculosis or other chronic or recurrent infectious disease
- Known history of lymphoproliferative disease
- Known malignancy or history of malignancy
Data sourced from ClinicalTrials.gov (NCT01059773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.