A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.
This trial comprises a total observation period of up to 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
469
RTX-GRT7039 intra-articular injection.
Placebo matching RTX-GRT7039 intra-articular injection.
Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12
Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
Time frame: Baseline up to Week 12
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26
Difference in mean change from baseline in WOMAC pain subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
Time frame: From Baseline up to Week 26
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52
Difference in mean change from baseline in WOMAC pain subscale score at Week 52 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
Time frame: From Baseline up to Week 52
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12
Difference in mean change from baseline in WOMAC physical function subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
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Cook Street Medical Clinic
Victoria, British Columbia, Canada
Dr. M. B. Jones
Victoria, British Columbia, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Malton Medical Research
Mississauga, Ontario, Canada
GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
Sainte-Foy, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Diex Recherche Victoriaville Inc.
Victoriaville, Quebec, Canada
Lekarna U Svate Anny
Písek, Czech Republic, Czechia
Revmatologie s.r.o.
Brno, Czechia
Interni A Revmatologicka Ambulance
Břeclav, Czechia
...and 93 more locations
Time frame: From Baseline up to Week 12
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26
Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
Time frame: From Baseline up to Week 26
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52
Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
Time frame: From Baseline up to Week 52