Trial Outcomes & Findings for Usability of an AI for M923 in Subjects With Moderate to Severe RA (NCT NCT02722044)

NCT ID: NCT02722044

Last Updated: 2018-05-16

Results Overview

The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 33 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2018-05-16

Participant Flow

A total of 51 participants were screened, and 33 participants were enrolled in the study.

Participant milestones

Measure	M923 40 mg Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Overall Study STARTED	33
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	M923 40 mg Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Overall Study Adverse Event	2
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Did Not Meet Criteria at Week 14	1

Baseline Characteristics

Usability of an AI for M923 in Subjects With Moderate to Severe RA

Baseline characteristics by cohort

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Age, Continuous	58.2 years STANDARD_DEVIATION 9.82 • n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	29 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Usability Analysis Set: all participants in the Safety Analysis Set who had usability measurements at Week 4 and who did not have any deviations from the protocol deemed significant enough for exclusion from the usability analysis

The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Usability of the Auto-injector (AI) at Week 4 Feelings about injections: PRE	8.15 Scores on a scale Standard Deviation 2.049
Usability of the Auto-injector (AI) at Week 4 Feelings about injections: POST	8.17 Scores on a scale Standard Deviation 1.930
Usability of the Auto-injector (AI) at Week 4 Self-image: POST	9.27 Scores on a scale Standard Deviation 2.061
Usability of the Auto-injector (AI) at Week 4 Self-confidence: PRE	8.12 Scores on a scale Standard Deviation 2.183
Usability of the Auto-injector (AI) at Week 4 Self-confidence: POST	8.39 Scores on a scale Standard Deviation 2.287
Usability of the Auto-injector (AI) at Week 4 Pain/skin reactions during/after injection: POST	9.33 Scores on a scale Standard Deviation 0.630
Usability of the Auto-injector (AI) at Week 4 Pain during/after injection: POST	8.76 Scores on a scale Standard Deviation 1.234
Usability of the Auto-injector (AI) at Week 4 Skin reactions: POST	9.90 Scores on a scale Standard Deviation 0.301
Usability of the Auto-injector (AI) at Week 4 Ease of use of the AI: POST	8.72 Scores on a scale Standard Deviation 2.072
Usability of the Auto-injector (AI) at Week 4 Satisfaction with self-injection: PRE	8.39 Scores on a scale Standard Deviation 1.887
Usability of the Auto-injector (AI) at Week 4 Satisfaction with self-injection: POST	8.89 Scores on a scale Standard Deviation 1.369

SECONDARY outcome

Timeframe: Week 4

Population: Usability Analysis Set

Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second "click" sound) were checked as "yes."

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Successful Injections as Assessed by the Observer at Week 4 Successfully completed P7, P10, and P11	31 Participants
Number of Participants With Successful Injections as Assessed by the Observer at Week 4 Successfully completed all 14 instructions	31 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Usability Analysis Set

Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as "no," the assessment was coded as hazard free.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4	31 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: Usability Analysis Set

The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Baseline. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Usability of the Auto-injector at Baseline Feelings about injections: PRE	7.20 Scores on a scale Standard Deviation 2.810
Usability of the Auto-injector at Baseline Feelings about injections: Post	7.98 Scores on a scale Standard Deviation 2.507
Usability of the Auto-injector at Baseline Self-image: POST	9.52 Scores on a scale Standard Deviation 1.357
Usability of the Auto-injector at Baseline Self-confidence: PRE	6.34 Scores on a scale Standard Deviation 3.218
Usability of the Auto-injector at Baseline Self-confidence: POST	7.96 Scores on a scale Standard Deviation 2.535
Usability of the Auto-injector at Baseline Pain/skin reactions: POST	8.99 Scores on a scale Standard Deviation 0.865
Usability of the Auto-injector at Baseline Pain during/after injection: POST	8.15 Scores on a scale Standard Deviation 1.591
Usability of the Auto-injector at Baseline Skin reaction: POST	9.84 Scores on a scale Standard Deviation 0.326
Usability of the Auto-injector at Baseline Ease of use of the AI: POST	8.26 Scores on a scale Standard Deviation 1.956
Usability of the Auto-injector at Baseline Satisfaction with AI: PRE	7.98 Scores on a scale Standard Deviation 2.365
Usability of the Auto-injector at Baseline Satisfaction with AI: POST	8.57 Scores on a scale Standard Deviation 1.490

SECONDARY outcome

Timeframe: Week 2

Population: Usability Analysis Set

The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Week 2. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Usability of the Auto-injector at Week 2 Feelings about injections: PRE	7.82 Scores on a scale Standard Deviation 2.294
Usability of the Auto-injector at Week 2 Feelings about injections: POST	8.06 Scores on a scale Standard Deviation 2.057
Usability of the Auto-injector at Week 2 Self-image: POST	9.60 Scores on a scale Standard Deviation 1.307
Usability of the Auto-injector at Week 2 Self-confidence: PRE	7.77 Scores on a scale Standard Deviation 2.311
Usability of the Auto-injector at Week 2 Self-confidence: POST	8.09 Scores on a scale Standard Deviation 2.319
Usability of the Auto-injector at Week 2 Pain/skin reactions: POST	9.22 Scores on a scale Standard Deviation 0.747
Usability of the Auto-injector at Week 2 Pain during/after injection: POST	8.55 Scores on a scale Standard Deviation 1.490
Usability of the Auto-injector at Week 2 Skin reactions: POST	9.89 Scores on a scale Standard Deviation 0.213
Usability of the Auto-injector at Week 2 Ease of use of the AI: POST	8.49 Scores on a scale Standard Deviation 2.098
Usability of the Auto-injector at Week 2 Satisfaction with AI: PRE	8.39 Scores on a scale Standard Deviation 1.773
Usability of the Auto-injector at Week 2 Satisfaction with AI: POST	8.65 Scores on a scale Standard Deviation 1.448

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: Usability Analysis Set

Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second "click" sound) were checked as "yes."

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Successful Injections as Assessed by the Observer at Baseline Successfully completed P7, P10, and P11	31 Participants
Number of Participants With Successful Injections as Assessed by the Observer at Baseline Successfully completed all 14 instructions	31 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: Usability Analysis Set

Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as "no," the assessment was coded as hazard free.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline	31 Participants

SECONDARY outcome

Timeframe: Week 2

Population: Usability Analysis Set

Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second "click" sound) were checked as "yes."

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Successful Injections as Assessed by the Observer at Week 2 Successfully completed P7, P10, and P11	31 Participants
Number of Participants With Successful Injections as Assessed by the Observer at Week 2 Successfully completed all 14 instructions	31 Participants

SECONDARY outcome

Timeframe: Week 2

Population: Usability Analysis Set

Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as "no," the assessment was coded as hazard free.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2	31 Participants

SECONDARY outcome

Timeframe: Baseline; 32 Weeks

Population: Safety Analysis Set: all participants who received study medication

Hematology, clinical chemistry, and urinalysis clinical laboratory parameters were assessed. The hematology panel consisted of complete blood count, hemoglobin, hematocrit, mean cell volume, total leukocytes, and platelet counts. The clinical chemistry panel consisted of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, lactate dehydrogenase, creatine kinase, C-reactive protein, cholesterol, triglycerides, total protein, sodium, potassium, chloride, blood urea nitrogen, creatinine, albumin, calcium, phosphate, glucose, glycosylated hemoglobin, uric acid, and bicarbonate. The urinalysis panel consisted of leucocytes, protein, bilirubin, urobilinogen, glucose, ketones, blood pH, nitrite, and specific gravity. Clinical significance was assessed by the Investigator.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments	0 Participants

SECONDARY outcome

Timeframe: 32 Weeks

Population: Safety Analysis Set

Vital signs included respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Vital Signs Outside the Expected Range	13 Participants

SECONDARY outcome

Timeframe: Baseline; 32 Weeks

Population: Safety Analysis Set

Clinical significance was assessed by the Investigator.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings	0 Participants

SECONDARY outcome

Timeframe: 32 Weeks

Population: Safety Analysis Set

The number of participants who had an adverse event that led to premature study withdrawal was assessed.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Adverse Events Leading to Premature Study Withdrawal	2 Participants

SECONDARY outcome

Timeframe: 32 Weeks

Population: Safety Analysis Set

An injection site reaction is defined as pain, tenderness, erythema/redness, induration/swelling, and other. If an injection site reaction was observed, a physician was to characterize and document the reaction as an adverse event (AE). Treatment-emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity on or after the first dose of study medication, until study completion/withdrawal or within 30 days following the last treatment for early withdrawn participants.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Number of Participants With Treatment-emergent Injection Site Reactions	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: Safety Analysis Set

A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline Overall ADA/positive predose	27 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline Overall ADA/negative predose	6 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.

A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=32 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4 Overall ADA/negative	6 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4 Overall ADA/positive	26 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.

A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=23 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12 Overall ADA/negative	5 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12 Overall ADA/positive	18 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.

A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=22 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24 Overall ADA/negative	5 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24 Overall ADA/positive	17 Participants

SECONDARY outcome

Timeframe: Safety Follow-Up Visit (32 Weeks)

Population: Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.

A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit Overall ADA/negative	6 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit Overall ADA/positive	25 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: Safety Analysis Set

A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=33 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline Overall nADA/positive	7 Participants
Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline Overall nADA/negative	26 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.

A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=32 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4 Overall nADA/negative	26 Participants
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4 Overall nADA/positive	6 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.

A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=23 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12 Overall nADA/negative	17 Participants
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12 Overall nADA/positive	6 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.

A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=22 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24 Overall nADA/negative	18 Participants
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24 Overall nADA/positive	4 Participants

SECONDARY outcome

Timeframe: Safety Follow-Up Visit (32 Weeks)

Population: Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.

A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.

Outcome measures

Measure	M923 40 mg n=31 Participants Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit Overall nADA/positive	7 Participants
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit Overall nADA/negative	24 Participants

Adverse Events

M923 40 mg

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	M923 40 mg n=33 participants at risk Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
Gastrointestinal disorders Duodenal ulcer perforation	3.0% 1/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	3.0% 1/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
Nervous system disorders Syncope	3.0% 1/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication

Other adverse events

Measure	M923 40 mg n=33 participants at risk Participants self-administered 40 milligrams (mg) of M923 every 2 weeks, as a subcutaneous injection using an auto-injector, for up to a maximum of 32 weeks.
General disorders Administrative site pain	6.1% 2/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site bruising	15.2% 5/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site coldness	12.1% 4/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site erythema	30.3% 10/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site induration	6.1% 2/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site pain	81.8% 27/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site pruritus	12.1% 4/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
General disorders Injection site swelling	15.2% 5/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
Infections and infestations Nasopharyngitis	6.1% 2/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.1% 2/33 • From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks) Safety Analysis Set: all participants who received study medication

Additional Information

Jim Jin

Momenta

Phone: +16173954905

Email: jjin@momentapharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place