Trial Outcomes & Findings for Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee (NCT NCT05377489)
NCT ID: NCT05377489
Last Updated: 2025-11-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
714 participants
Primary outcome timeframe
From Baseline up to Week 78
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
RTX-GRT7039
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
|
|---|---|
|
Overall Study
STARTED
|
714
|
|
Overall Study
COMPLETED
|
539
|
|
Overall Study
NOT COMPLETED
|
175
|
Reasons for withdrawal
| Measure |
RTX-GRT7039
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
122
|
|
Overall Study
Lost to Follow-up
|
21
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
RTX-GRT7039
n=714 Participants
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
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Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.72 • n=30 Participants
|
|
Sex: Female, Male
Female
|
548 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
574 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 78Outcome measures
| Measure |
RTX-GRT7039
n=714 Participants
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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394 Participants
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PRIMARY outcome
Timeframe: From Baseline up to Week 78Outcome measures
| Measure |
RTX-GRT7039
n=714 Participants
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
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Number of Participants With TEAEs Leading to Study Discontinuation
|
9 Participants
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SECONDARY outcome
Timeframe: From Baseline up to Week 78Outcome measures
| Measure |
RTX-GRT7039
n=714 Participants
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
|
Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods
|
7 Participants
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SECONDARY outcome
Timeframe: From Baseline up to Week 12Population: Results reported separately for Index Knee and Non-index Knee
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Outcome measures
| Measure |
RTX-GRT7039
n=698 Participants
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with OA of the knee, despite receiving continued treatment with optimal SoC or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with higher pain severity), or both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
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|---|---|
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Change From Baseline in WOMAC Pain Subscale Score
Index Knee
|
-2.73 units on a scale
Standard Deviation 2.053
|
|
Change From Baseline in WOMAC Pain Subscale Score
Non-index Knee
|
-2.33 units on a scale
Standard Deviation 1.944
|
Adverse Events
RTX-GRT7039
Serious events: 58 serious events
Other events: 54 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
RTX-GRT7039
n=714 participants at risk
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain severity), or each of both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
|
|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.56%
4/714 • Number of events 4 • Up to 78 weeks
|
|
Infections and infestations
Pneumonia
|
0.28%
2/714 • Number of events 2 • Up to 78 weeks
|
|
Infections and infestations
Localised infection
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Infections and infestations
Otitis media
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Infections and infestations
Sepsis
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
2/714 • Number of events 2 • Up to 78 weeks
|
|
Cardiac disorders
Aortic valve disease
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.28%
2/714 • Number of events 2 • Up to 78 weeks
|
|
Nervous system disorders
Dizziness
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.28%
2/714 • Number of events 2 • Up to 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Vascular disorders
Aortic rupture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
18/714 • Number of events 19 • Up to 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.70%
5/714 • Number of events 5 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
1/714 • Number of events 1 • Up to 78 weeks
|
Other adverse events
| Measure |
RTX-GRT7039
n=714 participants at risk
* RTX-GRT7039 was administered as an intra-articular injection or repeated intra-articular injections of RTX-GRT7039 in participants with moderate to severe pain associated with osteoarthritis (OA) of the knee, despite receiving continued treatment with optimal standard-of-care (SoC) or who are unable to receive SoC treatment due to contraindications or intolerability.
* Participants received injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain severity), or each of both knees up to Week 52.
* Participants received up to four repeated injections between 3 and 12 months after the first injection based on the persistence or return of pain, with a minimum interval of 12 weeks between injections.
|
|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.6%
54/714 • Number of events 74 • Up to 78 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER