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| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 20001 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Autoimmunity Centers of Excellence | OTHER |
| Rho Federal Systems Division, Inc. | INDUSTRY |
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Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.
Additionally, there are 4 optional sub-studies as part of the trial:
RA is characterized by persistent inflammation of peripheral joints, causing pain, stiffness, swelling and warmth. Over the past 10 years, advancements in biotechnology have revolutionized RA therapeutics with biologically-derived immunomodulating compounds. TNF-alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.
This study will last 24 weeks. Participants will be randomized into one of two treatment groups. Participants in one group will receive a dose of etanercept once every week for 24 weeks. Participants in the other group will receive a dose of adalimumab once every 2 weeks for 24 weeks.
This study consists of seven study visits after randomization and will occur at study entry and Weeks 4, 8, 12, 16, 20 and 24. Blood collection will occur at all study visits. A written participant assessment, vital signs, and physical exam will occur at study entry and Weeks 12 and 24. Follow-up calls to assess safety are scheduled for Weeks 4, 8, 16, and 20.
Additionally, participants will be offered the opportunity to enter one of four sub-studies as mentioned in the brief summary above: B Cell Kinetic Sub-Study, Vaccine Response Sub-Study, Tonsil Biopsy Sub-Study, and Synovial Biopsy Sub-Study. More information on these sub-studies is in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | Participants receive a subcutaneous injection of etanercept once every week for 24 weeks |
|
| Adalimumab | Experimental | Participants receive a subcutaneous injection of adalimumab once every 2 weeks for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | 50 mg dose of etanercept by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of CD27+ Switched Memory B Cells at Week 12 | Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 12 | Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline -Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A. Anolik, MD, PhD | University of Rochester | Study Chair |
| Inaki Sanz, MD | University of Rochester | Study Chair |
| R. John Looney, MD | University of Rochester | Study Chair |
| Meggan Mackay, MD | The Feinstein Institute for Medical Research NS-LIJ Health System | Principal Investigator |
| Jeffrey Curtis, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18937634 | Background | Bingham CO 3rd. Emerging therapeutics for rheumatoid arthritis. Bull NYU Hosp Jt Dis. 2008;66(3):210-5. | |
| 19149036 | Background | Otomo K, Koike T. [TNF inhibitors for treatment of rheumatoid arthritis]. Nihon Naika Gakkai Zasshi. 2008 Oct 10;97(10):2405-12. doi: 10.2169/naika.97.2405. No abstract available. Japanese. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY824 | Individual Participant Data Set | View IPD |
The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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On average, within 24 months after database lock for the trial.
Open access.
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Participants were to be recruited from seven sites in the United States. Recruitment occurred at six sites. The first site was activated in April 2009. The first participant was randomized in July 2009 and the last participant was randomized in July 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. |
| FG001 | Adalimumab | Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either etanercept or adalimumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. |
| BG001 | Adalimumab | Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 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 | Percentage of CD27+ Switched Memory B Cells at Week 12 | Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling. | The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations. | Posted | Mean | Standard Deviation | Percentage of B Cells | Week 12 |
|
From the time of administration of the first dose of study drug until the participant completed study participation, an average of 24 weeks, or until 30 days after the participant prematurely withdrew.
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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 | Etanercept | Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Adalimumab | Drug | 40 mg dose of adalimumab by subcutaneous injection |
|
|
| Week 12 |
| Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24 | Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline -Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis. | Week 24 |
| Percentage of Participants Meeting ACR20 Response Criteria at Week 12 | The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | Week 12 |
| Percentage of Participants Meeting ACR20 Response Criteria at Week 24 | The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | Week 24 |
| Percentage of Participants Meeting ACR50 Response Criteria at Week 12 | The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | Week 12 |
| Percentage of Participants Meeting ACR50 Response Criteria at Week 24 | The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | Week 24 |
| San Francisco |
| California |
| 94143 |
| United States |
| Yale University School Medicine | New Haven | Connecticut | 06519 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| 18677056 | Background | Soen S. [Daily practice using the guidelines for prevention and treatment of osteoporosis. The effects of anti-TNF therapy on bone and joint manifestations in rheumatoid arthritis]. Clin Calcium. 2008 Aug;18(8):1169-75. Japanese. |
| 34347945 | Result | Meednu N, Barnard J, Callahan K, Coca A, Marston B, Thiele R, Tabechian D, Bolster M, Curtis J, Mackay M, Graf J, Keating R, Smith E, Boyle K, Keyes-Elstein L, Welch B, Goldmuntz E, Anolik JH. Activated Peripheral Blood B Cells in Rheumatoid Arthritis and Their Relationship to Anti-Tumor Necrosis Factor Treatment and Response: A Randomized Clinical Trial of the Effects of Anti-Tumor Necrosis Factor on B Cells. Arthritis Rheumatol. 2022 Feb;74(2):200-211. doi: 10.1002/art.41941. Epub 2021 Dec 27. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
The Immunology Database and Analysis Portal (ImmPort) is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. The portal includes available analysis tools for researchers. |
| SDY824 | Study Protocol | View IPD | ImmPort study identifier is SDY824. |
| SDY824 | Study summary, -design, -adverse event(s), -summary of participant assessments, -medications, -demographics, -lab tests, -mechanistic assays, -study files et al. | View IPD | ImmPort study identifier is SDY824. |
| Withdrawn by sponsor/regulatory agency |
|
| Noncompliant |
|
| Baseline assessments not done in time |
|
| Unable to obtain study drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Detection of Either IgM-Rheumatoid Factor or Antibodies to Cyclic Citrullinated Peptide | Serum IgM-Rheumatoid Factor (IgM RF) is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage. Antibodies to Cyclic Citrullinated Peptide (anti-CCP) is often detected in in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage. | Number | participants |
|
| Detection of IgM-Rheumatoid Factor (IgM RF) | Serum IgM RF is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage. | Number | participants |
|
| Detection of Antibodies to Cyclic Citrullinated Antibody Peptide | Anti-CCP is often present in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage. | Number | participants |
|
| Methotrexate Dosage | Participants were required to be on a stable dose of methotrexate to be enrolled in the study. Stable dose definition: between 7.5 mg and 25 mg by mouth or subcutaneously weekly for at least 8 weeks prior to randomization. | Mean | Standard Deviation | mg |
|
| Years with Rheumatoid Arthritis | Years since diagnosis of rheumatoid arthritis by a physician. Participants were required to be diagnosed with Rheumatoid Arthritis at least 3 months before enrolling in the study. | Mean | Standard Deviation | years |
|
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker, or help is received from another person in the daily living activities. Scores from each of the 8 categories are totaled and can range from 0 to 24. | Mean | Standard Deviation | scores on a scale |
|
| C-reactive Protein (CRP) Level | CRP is an acute phase reactant that is used to identify the presence of nonspecific inflammation. The CRP normal reference range depends on the laboratory. In this study the upper limit of normal ranged from 4 to 10.9 mg/L. An increased CRP level indicated the presence of inflammation. A low CRP may mean an absence of inflammation. | Mean | Standard Deviation | mg/L |
|
| Tender Joint Count | Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints examined. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. | Mean | Standard Deviation | Joints |
|
| Swollen Joint Count at Baseline | Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints examined. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. | Mean | Standard Deviation | Joints |
|
| Patient's Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) | A self-reported measure of perceived disease activity obtained by responding to the question "considering all the ways that your arthritis affects you, rate how you are doing on the following scale by placing a vertical mark." A vertical mark on a 10 cm line rated 0 (very well) to 10 (very bad) determines the score. The range: 0 to 10, with 10 being severe symptoms). | Mean | Standard Deviation | cm |
|
| Disease Activity Score Using C-reactive Protein (DAS28-CRP) | The DAS28 is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein (CRP) in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Mean | Standard Deviation | scores on a scale |
|
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
| OG001 | Adalimumab | Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks. |
|
|
|
| Secondary | Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 12 | Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline -Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24 | Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline -Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants Meeting ACR20 Response Criteria at Week 12 | The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants Meeting ACR20 Response Criteria at Week 24 | The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants Meeting ACR50 Response Criteria at Week 12 | The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants Meeting ACR50 Response Criteria at Week 24 | The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
Participants with measurements for designated time points were included in the analysis. | The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| 2 |
| 39 |
| 31 |
| 39 |
| EG001 | Adalimumab | Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks. | 1 | 19 | 17 | 19 |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |