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The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Experimental | All study participants to receive M923 administered via a subcutaneous auto-injector (AI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M923 | Biological | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the Auto-injector (AI) at Week 4 | 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Injections as Assessed by the Observer at Week 4 | 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." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Caminis, MD | Baxalta US Inc., now part of Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Medication Management, LLC |
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A total of 51 participants were screened, and 33 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: all participants who received study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of the Auto-injector (AI) at Week 4 | 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. | 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 | Posted | Mean | Standard Deviation | Scores on a scale | Week 4 |
From the date of Screening until the Safety Follow-Up Visit (approximately 32 weeks)
Safety Analysis Set: all participants who received study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administrative site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Jin | Momenta | +16173954905 | jjin@momentapharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2016 | Mar 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2016 | Mar 29, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Autoinjector | Device | Subcutaneous administration |
|
| Week 4 |
| Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4 | 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. | Week 4 |
| Usability of the Auto-injector at Baseline | 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. | Baseline (Day 1) |
| Usability of the Auto-injector at Week 2 | 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. | Week 2 |
| Number of Participants With Successful Injections as Assessed by the Observer at Baseline | 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." | Baseline (Day 1) |
| Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline | 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. | Baseline (Day 1) |
| Number of Participants With Successful Injections as Assessed by the Observer at Week 2 | 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." | Week 2 |
| Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2 | 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. | Week 2 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | 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. | Baseline; 32 Weeks |
| Number of Participants With Vital Signs Outside the Expected Range | Vital signs included respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure. | 32 Weeks |
| Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings | Clinical significance was assessed by the Investigator. | Baseline; 32 Weeks |
| Number of Participants With Adverse Events Leading to Premature Study Withdrawal | The number of participants who had an adverse event that led to premature study withdrawal was assessed. | 32 Weeks |
| Number of Participants With Treatment-emergent Injection Site Reactions | 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. | 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 | 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. | Baseline (Day 1) |
| Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4 | 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. | Week 4 |
| Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12 | 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. | Week 12 |
| Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24 | 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. | Week 24 |
| 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 | 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. | Safety Follow-Up Visit (32 Weeks) |
| Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline | 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. | Baseline (Day 1) |
| Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4 | 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. | Week 4 |
| Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12 | 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. | Week 12 |
| Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24 | 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. | Week 24 |
| Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit | 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. | Safety Follow-Up Visit (32 Weeks) |
| Greensboro |
| North Carolina |
| 27408 |
| United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Altoona Center for Clinical Research, PC | Duncansville | Pennsylvania | 16635 | United States |
| Austin Regional Clinic, PA | Austin | Texas | 78731 | United States |
| Accurate Clinical Management | Houston | Texas | 77004 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | United States |
| Did Not Meet Criteria at Week 14 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
|
|
| Secondary | Number of Participants With Successful Injections as Assessed by the Observer at Week 4 | 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." | Usability Analysis Set | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4 | 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. | Usability Analysis Set | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Usability of the Auto-injector at Baseline | 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. | Usability Analysis Set | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) |
|
|
|
| Secondary | Usability of the Auto-injector at Week 2 | 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. | Usability Analysis Set | Posted | Mean | Standard Deviation | Scores on a scale | Week 2 |
|
|
|
| Secondary | Number of Participants With Successful Injections as Assessed by the Observer at Baseline | 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." | Usability Analysis Set | Posted | Count of Participants | Participants | Baseline (Day 1) |
|
|
|
| Secondary | Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline | 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. | Usability Analysis Set | Posted | Count of Participants | Participants | Baseline (Day 1) |
|
|
|
| Secondary | Number of Participants With Successful Injections as Assessed by the Observer at Week 2 | 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." | Usability Analysis Set | Posted | Count of Participants | Participants | Week 2 |
|
|
|
| Secondary | Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2 | 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. | Usability Analysis Set | Posted | Count of Participants | Participants | Week 2 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | 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. | Safety Analysis Set: all participants who received study medication | Posted | Count of Participants | Participants | Baseline; 32 Weeks |
|
|
|
| Secondary | Number of Participants With Vital Signs Outside the Expected Range | Vital signs included respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure. | Safety Analysis Set | Posted | Count of Participants | Participants | 32 Weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings | Clinical significance was assessed by the Investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline; 32 Weeks |
|
|
|
| Secondary | Number of Participants With Adverse Events Leading to Premature Study Withdrawal | The number of participants who had an adverse event that led to premature study withdrawal was assessed. | Safety Analysis Set | Posted | Count of Participants | Participants | 32 Weeks |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Injection Site Reactions | 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. | Safety Analysis Set | Posted | Count of Participants | Participants | 32 Weeks |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline | 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. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline (Day 1) |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4 | 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. | Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12 | 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. | Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24 | 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. | Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | 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 | 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. | Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed. | Posted | Count of Participants | Participants | Safety Follow-Up Visit (32 Weeks) |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline | 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. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline (Day 1) |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4 | 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. | Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12 | 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. | Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24 | 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. | Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit | 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. | Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed. | Posted | Count of Participants | Participants | Safety Follow-Up Visit (32 Weeks) |
|
|
|
| 0 |
| 33 |
| 2 |
| 33 |
| 31 |
| 33 |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site coldness | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Self-confidence: PRE |
|
| Self-confidence: POST |
|
| Pain/skin reactions: POST |
|
| Pain during/after injection: POST |
|
| Skin reaction: POST |
|
| Ease of use of the AI: POST |
|
| Satisfaction with AI: PRE |
|
| Satisfaction with AI: POST |
|
| Title | Measurements |
|---|---|
|
| Self-confidence: PRE |
|
| Self-confidence: POST |
|
| Pain/skin reactions: POST |
|
| Pain during/after injection: POST |
|
| Skin reactions: POST |
|
| Ease of use of the AI: POST |
|
| Satisfaction with AI: PRE |
|
| Satisfaction with AI: POST |
|