Trial Outcomes & Findings for RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints (NCT NCT02771860)

Last Updated: 2024-09-25

Results Overview

The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair (better outcome), and negative changes with erosive progression (worse outcome).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator: Experimental: Denosumab 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Overall Study STARTED	51	49
Overall Study COMPLETED	46	46
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: Experimental: Denosumab n=51 Participants 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=49 Participants 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=99 Participants	40 Participants n=107 Participants	82 Participants n=206 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Age, Continuous	62.0 years STANDARD_DEVIATION 7.7 • n=99 Participants	60.6 years STANDARD_DEVIATION 7.9 • n=107 Participants	61.3 years STANDARD_DEVIATION 7.8 • n=206 Participants
Sex: Female, Male Female	41 Participants n=99 Participants	37 Participants n=107 Participants	78 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	12 Participants n=107 Participants	22 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=99 Participants	49 Participants n=107 Participants	100 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Body mass index	25.3 kg/m² STANDARD_DEVIATION 3.5 • n=99 Participants	25.3 kg/m² STANDARD_DEVIATION 4.0 • n=107 Participants	25.3 kg/m² STANDARD_DEVIATION 3.8 • n=206 Participants
Number of radiographically affected joints	3.6 count STANDARD_DEVIATION 2.2 • n=99 Participants	4.0 count STANDARD_DEVIATION 2.2 • n=107 Participants	3.8 count STANDARD_DEVIATION 2.2 • n=206 Participants
Ghent University scoring system (GUSS) of all joints	249 units on a scale STANDARD_DEVIATION 66 • n=99 Participants	248 units on a scale STANDARD_DEVIATION 67 • n=107 Participants	249 units on a scale STANDARD_DEVIATION 67 • n=206 Participants
Ghent University scoring system (GUSS) of target joints	155.9 units on a scale STANDARD_DEVIATION 69.3 • n=99 Participants	158.7 units on a scale STANDARD_DEVIATION 46.8 • n=107 Participants	157.3 units on a scale STANDARD_DEVIATION 58.3 • n=206 Participants
Pain	4.7 units on a scale STANDARD_DEVIATION 2.5 • n=99 Participants	4.8 units on a scale STANDARD_DEVIATION 2.7 • n=107 Participants	4.8 units on a scale STANDARD_DEVIATION 2.7 • n=206 Participants
Australian-Canadian Hand Osteoarthritis index, subscale pain	20.7 units on a scale STANDARD_DEVIATION 11.6 • n=99 Participants	21.7 units on a scale STANDARD_DEVIATION 13.0 • n=107 Participants	21.2 units on a scale STANDARD_DEVIATION 12.3 • n=206 Participants
Australian-Canadian Hand Osteoarthritis index, subscale function	41.3 units on a scale STANDARD_DEVIATION 21.9 • n=99 Participants	42.0 units on a scale STANDARD_DEVIATION 24.9 • n=107 Participants	41.6 units on a scale STANDARD_DEVIATION 23.4 • n=206 Participants
Functional Index for Hand Osteoarthritis (FIHOA)	10.4 units on a scale STANDARD_DEVIATION 0.9 • n=99 Participants	10.3 units on a scale STANDARD_DEVIATION 1.0 • n=107 Participants	10.4 units on a scale STANDARD_DEVIATION 1.0 • n=206 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)

Outcome measures

Outcome measures
Measure	Active Comparator: Experimental: Denosumab n=51 Participants 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=49 Participants 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Total Ghent University Scoring System (GUSS) of Target Joints at Week 24	162.2 units on a scale Standard Error 2.4	153.3 units on a scale Standard Error 3.2

SECONDARY outcome

Timeframe: 48 weeks

Population: intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)

These are the number of new erosive IP joints according to the Verbruggen and Veys anatomical scoring system amongst the pre-erosive joints (i.e., N, S, J joints) at 48 weeks.

Outcome measures

Outcome measures
Measure	Active Comparator: Experimental: Denosumab n=501 joints 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=535 joints 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Number of New Erosive Joints by Verbruggen and Veys at Week 48	9 joints	38 joints

SECONDARY outcome

Timeframe: 48 weeks

Population: intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)

Outcome measures

Outcome measures
Measure	Active Comparator: Experimental: Denosumab n=46 Participants 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=46 Participants 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Total Ghent University Scoring System (GUSS) at Week 48	163.5 units on a scale Standard Error 2.9	149.2 units on a scale Standard Error 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 weeks

Number of patients who have experienced one or more (serious) adverse events throughout the study

Outcome measures

Outcome data not reported

Adverse Events

Active Comparator: Experimental: Denosumab

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Comparator - Placebo

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Comparator: Experimental: Denosumab n=51 participants at risk 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=49 participants at risk 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Cardiac disorders Major cardiovascular event	2.0% 1/51 • Number of events 1 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	0.00% 0/49 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/51 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	6.1% 3/49 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Surgical and medical procedures Surgical and medical procedures	3.9% 2/51 • Number of events 2 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	6.1% 3/49 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Musculoskeletal and connective tissue disorders Musculoskeletal complaints	5.9% 3/51 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	0.00% 0/49 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Infections and infestations Infections	0.00% 0/51 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	2.0% 1/49 • Number of events 1 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.

Other adverse events

Other adverse events
Measure	Active Comparator: Experimental: Denosumab n=51 participants at risk 51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.	Comparator - Placebo n=49 participants at risk 49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.
Infections and infestations Infection	51.0% 26/51 • Number of events 41 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	44.9% 22/49 • Number of events 38 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Gastrointestinal disorders Gastrointestinal event	9.8% 5/51 • Number of events 6 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	12.2% 6/49 • Number of events 7 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Surgical and medical procedures Surgical and medical procedures	0.00% 0/51 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	10.2% 5/49 • Number of events 6 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Musculoskeletal and connective tissue disorders Musculoskeletal complaints	37.3% 19/51 • Number of events 24 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	49.0% 24/49 • Number of events 34 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Nervous system disorders Nervous system disorders (incl. dizziness, vertigo, headache)	7.8% 4/51 • Number of events 4 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	22.4% 11/49 • Number of events 17 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Respiratory, thoracic and mediastinal disorders Pulmonary and respiratory complaintes (non-infectious)	3.9% 2/51 • Number of events 2 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	2.0% 1/49 • Number of events 1 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Skin and subcutaneous tissue disorders Rash and skin problmes	5.9% 3/51 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	2.0% 1/49 • Number of events 1 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
Immune system disorders Allergy (systemic and urticaria)	5.9% 3/51 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	2.0% 1/49 • Number of events 1 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
General disorders Theet problems	5.9% 3/51 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	6.1% 3/49 • Number of events 3 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.
General disorders Other	7.8% 4/51 • Number of events 5 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.	18.4% 9/49 • Number of events 10 • Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.

Additional Information

Prof. dr. Ruth Wittoek

University Gent

Phone: +3293322522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place