Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis
Sponsor: Radboud University Medical Center
Listed as NCT00241982, this PHASE2 trial focuses on Rheumatoid Arthritis and remains completed. Sponsored by Radboud University Medical Center, it has been updated 7 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)A proof of concept, dose-escalating trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
Secondary goals: To compare the therapeutic effect of this intervention with that of a single intramuscular administration of 120 mg methylprednisolone (Depo-Medrol, Pharmacia). The latter is commonly used in the clinics as bridging therapy. To assess the effect of these interventions at the synovial tissue level.
On the longer term, the goal of liposomal corticosteroids is to achieve an increased efficacy/safety ratio compared to standard treatment with free corticosteroids.
A proof of concept, dose-escalating trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.
Secondary goals: To compare the therapeutic effect of this intervention with that of a single intramuscular administration of 120 mg methylprednisolone (Depo-Medrol, Pharmacia). The latter is commonly used in the clinics as bridging therapy. To assess the effect of these interventions at the synovial tissue level.
On the longer term, the goal of liposomal corticosteroids is to achieve an increased efficacy/safety ratio compared to standard treatment with free corticosteroids.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Mar 2022 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Mar 2022 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Oct 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Radboud University Medical Center
- Utrecht University
For direct contact, visit the study record on ClinicalTrials.gov .