Osteoarthritis
Conditions
Keywords
Knee, Osteoarthritis, Pain assessment
Brief summary
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
Detailed description
This trial comprises a total observation period of up to 78 weeks.
Interventions
DRUGRTX-GRT7039
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.
Sponsors
Grünenthal GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participant has given written informed consent to participate. * The participant is 18 years of age or older at the Screening Visit. * The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III. * There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.
Exclusion criteria
* The participant has past joint replacement surgery of the index knee. * The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening. * The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis. * The participant has clinical hip osteoarthritis on the side of the index knee. * The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee. * The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10°, valgus \>10°) by radiograph as assessed by independent Central Readers at Screening Visit. * The participant has other conditions that could affect trial endpoint assessments of the index knee. * The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial. * The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers). * The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit. * The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator. The non-index knee is not eligible for treatment in the trial, if any of the knee-related
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From Baseline up to Week 78 |
| Number of Participants With TEAEs Leading to Study Discontinuation | From Baseline up to Week 78 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods | From Baseline up to Week 78 | — |
| Change From Baseline in WOMAC Pain Subscale Score | From Baseline up to Week 12 | The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain. |
Countries
Bulgaria, Japan, Poland, Romania, South Africa, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 714 |
| Total | 714 |
Baseline characteristics
| Characteristic | RTX-GRT7039 |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 8.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 52 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 574 Participants |
| Sex: Female, Male Female | 548 Participants |
| Sex: Female, Male Male | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 714 |
| other Total, other adverse events | 54 / 714 |
| serious Total, serious adverse events | 58 / 714 |
Outcome results
Primary
Number of Participants With TEAEs Leading to Study Discontinuation
Time frame: From Baseline up to Week 78
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTX-GRT7039 | Number of Participants With TEAEs Leading to Study Discontinuation | 9 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Baseline up to Week 78
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTX-GRT7039 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 394 Participants |
Secondary
Change From Baseline in WOMAC Pain Subscale Score
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Time frame: From Baseline up to Week 12
Population: Results reported separately for Index Knee and Non-index Knee
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTX-GRT7039 | Change From Baseline in WOMAC Pain Subscale Score | Index Knee | -2.73 units on a scale | Standard Deviation 2.053 |
| RTX-GRT7039 | Change From Baseline in WOMAC Pain Subscale Score | Non-index Knee | -2.33 units on a scale | Standard Deviation 1.944 |
Secondary
Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods
Time frame: From Baseline up to Week 78
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTX-GRT7039 | Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods | 7 Participants |