Trial Outcomes & Findings for MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis (NCT NCT04204265)

NCT ID: NCT04204265

Last Updated: 2025-01-28

Results Overview

Mean change in Numerical Rating Scale (NRS) Pain in the Index Shoulder from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

From Baseline to 6 Months

Results posted on

2025-01-28

Participant Flow

Only one shoulder \[Index Shoulder\] of each participant was included in this study.

Participant milestones

Participant milestones
Measure	Monovisc Single injection of Monovisc into the Index Shoulder
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MONOVISC for Shoulder Joint Pain Relief Due to Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
Age, Continuous	64.48 years STANDARD_DEVIATION 9.02 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Index Shoulder Right	19 Participants n=5 Participants
Index Shoulder Left	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean change in Numerical Rating Scale (NRS) Pain in the Index Shoulder from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
Numerical Rating Scale (NRS) Pain	-4.12 score on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean change in the Index Shoulder Disabilities of the Arm, Shoulder and Hand (DASH) Index from baseline to 6 months post injection. The DASH Index is a 30-item self-reported questionnaire on pain and function in which the response options are presented as 5-point Likert scales. Scores for each question range from 0=(no pain or disability) to 100=(most severe pain or disability) and are averaged to calculate the final DASH Index score. A negative value for the change in DASH Index score indicates improvement. A larger negative value indicates a higher level of improvement, and a better clinical outcome.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
Disabilities of Arm, Shoulder & Hand (DASH) Index	-36.22 score on a scale Standard Deviation 17.43

SECONDARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean change from baseline to 6 months in Index Shoulder pain post treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
Patient Global Assessment (PGA) Score	-4.16 score on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The post-treatment responder rate at 6 months as determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding to treatment indicates better clinical outcomes.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	23 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The usage of Rescue Medication (RM) at 6 months post treatment as based on the number of participants that were NOT using acetaminophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the Index Shoulder
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)	21 Participants

Adverse Events

Monovisc

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Monovisc n=25 participants at risk Single injection of Monovisc into the Index Shoulder
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 3 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Musculoskeletal and connective tissue disorders Joint Swelling	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Nervous system disorders Headache	4.0% 1/25 • Number of events 2 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Vascular disorders Hypertension	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).

Additional Information

Kara Mezger, Executive Director Clinical Affairs

Anika Therapeutics

Phone: 781.457.9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee INVESTIGATOR may publish the Data/Results with the consent of the SPONSOR if: 1. Publication is done after primary publication covering data from all participating sites, and provided the Data/Results do not contain any Confidential Information. 2. Eighteen (18) months has elapsed after entire completion of the Clinical Trial at all participating sites.
Publication restrictions are in place

Restriction type: OTHER