A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis

Conditions

Knee osteoarthritis

Brief summary

Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection

Detailed description

Evaluation of change from baseline in weekly average of knee pain as measured using a NRS, assessed at 3 months and 6 months from last study treatment., Change from baseline in WOMAC total score at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC pain sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC stiffness and disability sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in QoL as measured by Euro Quality of Life-5-dimension (EQ-5D) questionnaire at 6 months and at 12 months from last study treatment administration., Use of analgesics by 3 months, 6 months, and 12 months from last study treatment administration.

Related papers

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Interventions

DRUGMatching placebo (vehicle)

DRUGAllocetra-OTS

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection	—

Secondary

Measure	Time frame
Evaluation of change from baseline in weekly average of knee pain as measured using a NRS, assessed at 3 months and 6 months from last study treatment., Change from baseline in WOMAC total score at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC pain sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC stiffness and disability sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in QoL as measured by Euro Quality of Life-5-dimension (EQ-5D) questionnaire at 6 months and at 12 months from last study treatment administration., Use of analgesics by 3 months, 6 months, and 12 months from last study treatment administration.	—

Measure

Time frame

Evaluation of change from baseline in weekly average of knee pain as measured using a NRS, assessed at 3 months and 6 months from last study treatment., Change from baseline in WOMAC total score at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC pain sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in WOMAC stiffness and disability sub-scores at 3 months, 6 months, and 12 months from last study treatment administration., Change from baseline in QoL as measured by Euro Quality of Life-5-dimension (EQ-5D) questionnaire at 6 months and at 12 months from last study treatment administration., Use of analgesics by 3 months, 6 months, and 12 months from last study treatment administration.

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Countries

Denmark

Outcome results

None listed