This study is a multi-center, Phase 2, randomized, dose ranging, assessor-blinded, active and placebo-controlled, parallel-group prospective study evaluating the efficacy and safety of a single IA injection of various RTX doses, Zilretta or placebo for the treatment of pain due to moderate to severe osteoarthritis knee pain.
A planned 112 subjects will be randomized to one of 7 groups (n=16 each) with each subject receiving one IA injection in the index knee joint (the knee primarily affected by pain if bilateral).
This study is a Phase 1b proof-of-concept, open-label study to assess the safety and pilot efficacy of Enbrel administered by the Sofusa® DoseConnect™ delivery system (SOFUSA) for the treatment of patients with moderately to severe RA and an inadequate response to subcutaneous (SC) Enbrel. SOFUSA Enbrel will be administered once weekly to patients for 12 weeks. Patients will start on an Enbrel dose of 25 mg during the induction phase of the study and may be increased to an Enbrel dose of 50 mg during the dose escalation phase of the study based on the dose escalation criteria. Patients will remain on either the 25 mg or 50 mg dose for the final maintenance phase of the study.
This study is to evaluate the safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA). It is also to assess the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.