Rheumatoid ArthritisPhase 3NCT02722044
Usability of an AI for M923 in Subjects With Moderate to Severe RA
A Phase 3 study testing M923 and Autoinjector in people with Rheumatoid Arthritis, run by Momenta Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- M923 and Autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2016to 21 Feb 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥18 years old at the time of Screening
- Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
- RA diagnosed for at least 6 months before Screening
- Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
- Active disease at Screening and Baseline
- Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor
Show all 9Show fewer
- Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s)
- Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose.
- Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.
Who cannot join
- Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
- Prior use of rituximab
- Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
- Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
- Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
- Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
Show all 24Show fewer
- Current use of more than 1 nonsteroidal anti-inflammatory drug.
- Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline
- Prior or current use of other self-injected drugs, eg, insulin
- All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
- Meets Class IV Steinbrocker criteria for disability/activities of daily living
- Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
- Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
- Joint surgery within the last 8 weeks prior to Screening
- Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
- History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
- History or presence of Class III or IV New York Heart Association congestive heart failure
- History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas
- Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)
- History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus
- History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
- Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- Participant is a family member or employee of the Investigator or Baxalta or its partners
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Austin Regional Clinic, PA
Austin, Texas, 78731
Henry Ford Health System
Detroit, Michigan, 48202
Altoona Center for Clinical Research, PC
Duncansville, Pennsylvania, 16635
Medication Management, LLC
Greensboro, North Carolina, 27408
Accurate Clinical Management
Houston, Texas, 77004
Accurate Clinical Research, Inc.
Houston, Texas, 77034
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
About this study
Official title: An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
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)
- Conditions
- Rheumatoid Arthritis
- Being tested
- M923, Autoinjector
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M923Biological
Also called Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
AutoinjectorDevice
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Experimental | All study participants to receive M923 administered via a subcutaneous auto-injector (AI) Receives: Biological: M923; Device: Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (23)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 32 Weeks
Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings
Clinical significance was assessed by the Investigator.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Safety Follow-Up Visit (32 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Caminis, MD, Study director, Baxalta US Inc., now part of Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722044
- Sponsor's protocol ID
- 911502
- Status last verified
- May 2018
- First submitted
- 23 Mar 2016
- Last updated
- 16 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT02722044
- Acronym / sponsor ID
- 911502
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Experimental | Biological: M923, Device: AutoinjectorAll study participants to receive M923 administered via a subcutaneous auto-injector (AI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants ≥18 years old at the time of Screening
- Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
- RA diagnosed for at least 6 months before Screening
- Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
- Active disease at Screening and Baseline
Key exclusion criteria (24 listed)
- Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
- Prior use of rituximab
- Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
- Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
- Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M923Also: AdalimumabRecombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) | Biological | All Study Participants |
| AutoinjectorSubcutaneous administration | Device | All Study Participants |
Primary outcome
Usability of the Auto-injector (AI) at Week 4
Time frame: 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.
23 secondary outcomes
Number of Participants With Successful Injections as Assessed by the Observer at Week 4
Time frame: Week 4
Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4
Time frame: Week 4
Usability of the Auto-injector at Baseline
Time frame: Baseline (Day 1)
Usability of the Auto-injector at Week 2
Time frame: Week 2
Number of Participants With Successful Injections as Assessed by the Observer at Baseline
Time frame: Baseline (Day 1)
Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline
Time frame: Baseline (Day 1)
Number of Participants With Successful Injections as Assessed by the Observer at Week 2
Time frame: Week 2
Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2
Time frame: Week 2
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Baseline; 32 Weeks
Number of Participants With Vital Signs Outside the Expected Range
Time frame: 32 Weeks
Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings
Time frame: Baseline; 32 Weeks
Number of Participants With Adverse Events Leading to Premature Study Withdrawal
Time frame: 32 Weeks
Number of Participants With Treatment-emergent Injection Site Reactions
Time frame: 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
Time frame: 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
Time frame: Week 4
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12
Time frame: Week 12
Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24
Time frame: 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
Time frame: Safety Follow-Up Visit (32 Weeks)
Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline
Time frame: Baseline (Day 1)
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4
Time frame: Week 4
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12
Time frame: Week 12
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24
Time frame: Week 24
Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit
Time frame: Safety Follow-Up Visit (32 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Caminis, MD study director
Baxalta US Inc., now part of Shire
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing M923 and Autoinjector in people with Rheumatoid Arthritis, run by Momenta Pharmaceuticals, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Auto-injector (AI) at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.