Phase 3
Completed N=46
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
Plaque psoriasis · Rheumatoid Arthritis · Pustular Psoriasis (Excluding a Localized) · Psoriatic Erythroderma
Source: ClinicalTrials.gov NCT01680159 ↗
Enrolled (actual)
46
Serious AEs
5.8%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score — 0.0; 0.0; 0.0; 0.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score |
0.0; 0.0; 0.0; 0.0; 0.0; 13.7 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score |
14.70; 12.80; 13.95; 14.70; 22.20; 7.60 | — |
| SECONDARY Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) |
0.0; 32.3; 32.3; 43.3; 41.4; 57.1 | — |
| SECONDARY Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) |
59.5; 19.0; 49.5; 14.0; 41.0; 27.0 | — |
| SECONDARY Assessment of Severity (Only for Patients With Pustular Psoriasis) |
4.0; 3.0; 1.5; 1.5; 1.5; 2.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
- Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.
Exclusion Criteria
- Patients who have guttate psoriasis.
- Patients who have drug-induced psoriasis
- Patients who have previously used any other biological products than infliximab.
- Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
- Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
- Female patients who are pregnant, breast-feeding, or possibly pregnant.
Data sourced from ClinicalTrials.gov (NCT01680159). 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.