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Lack of Enrollment
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Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.
This study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in the adalimumab arm will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in the etanercept arm will receive subcutaneous etanercept injections.
This study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab / Adalimumab Placebo | Experimental | 1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks |
|
| Etanercept | Experimental | Participants will receive 1 SQ injection of etanercept each week for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | 40 mg injection of adalimumab administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Baseline, Week 12 |
| Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). |
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Inclusion Criteria:
Diagnosis of Rheumatoid Arthritis
Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization
Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4
Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:
If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.
If treated with prednisone (or equivalent corticosteroid), on a stable dose of <= 10 mg/day for 28 days prior to randomization.
Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Moreland, MD | University of Pittsburgh | Study Chair |
| Mark Genovese, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20386564 | Background | Villeneuve E, Haraoui B. To switch or to change class-the biologic dilemma in rheumatoid arthritis. Nat Rev Rheumatol. 2010 May;6(5):301-5. doi: 10.1038/nrrheum.2010.45. Epub 2010 Apr 13. | |
| 19368701 | Background | Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1(Suppl 1):S1. doi: 10.1186/ar2666. Epub 2009 Apr 6. |
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Each subject signed an informed consent prior to undergoing any screening procedures. At the screening visit, subjects underwent procedures to establish inclusion/exclusion criteria.
Subject recruitment occurred between November 2008 and November 2010 at 16 sites located in the United States. All sites utilized a rheumatology clinic and outside referrals for recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Switcher/Adalimumab Alternating With Placebo | Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adalimumab placebo | Drug | 1.0 ml .9% saline placebo administered subcutaneously |
|
|
| Etanercept | Drug | 50 mg dimeric fusion protein administered subcutaneously |
|
|
| Week 12 |
| Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Week 12 |
| Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response) | The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2. | Baseline, Week 12 |
| Participants With an ACR 20 Response 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:
| Week 12 |
| Participants With an ACR 50 Response 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:
| Week 12 |
| Participants With an ACR 70 Response at Week 12 | The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:
| Week 12 |
| Palo Alto |
| California |
| 94304 |
| United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Sarasota Arthritis Research Center | Sarasota | Florida | 34239 | United States |
| Tampa Medical Group | Tampa | Florida | 33614 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Justus Fiechtner, MD, PC | Lansing | Michigan | 48910 | United States |
| Feinstein Institute for Medical Research NS-LIJ | Manhassett | New York | 14642 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Carolina Bone and Joint | Charlotte | North Carolina | 28210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| Baylor Research Institute | Dallas | Texas | 75231 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 9778226 | Background | van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K. |
| FG001 | Non-Switcher/Etanercept | Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
| FG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| FG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Switcher/Adalimumab Alternating With Placebo | Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| BG001 | Non-Switcher/Etanercept | Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
| BG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| BG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Mean | Standard Deviation | Scores on a scale |
|
| 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 | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Intent-to-treat | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Intent-to-treat | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Intent-to-treat | Posted | Number | participants | Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 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 in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). | Intent-to-treat | Posted | Number | participants | Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response) | The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2. | Intent-to-treat | Posted | Number | participants | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With an ACR 20 Response 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:
| Intent-to-treat | Posted | Number | participants | Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With an ACR 50 Response 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:
| Intent-to-treat | Posted | Number | participants | Week 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Participants With an ACR 70 Response at Week 12 | The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:
| Intent-to-treat | Posted | Number | participants | Week 12 |
|
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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 | Non-Switcher/Adalimumab | Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab | 0 | 3 | 3 | 3 | ||
| EG001 | Non-Switcher/Etanercept | Subjects failing Etanercept at screening who were randomized to remain on Etanercept | 0 | 4 | 3 | 4 | ||
| EG002 | Switcher/Adalimumab to Etanercept | Subjects failing Adalimumab at screening who were randomized to switch to Etanercept | 0 | 4 | 4 | 4 | ||
| EG003 | Switcher/Etanercept to Adalimumab | Subjects failing Etanercept at screening who were randomized to switch to Adalimumab | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Gallop rhythm present | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prolonged expiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
The study terminated early due to recruitment feasibility issues. Thirteen subjects were enrolled and received treatment. No mechanistic analyses were performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
|
|
| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
|
|
| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
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| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
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| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
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| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
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| OG002 | Switcher/Adalimumab to Etanercept | Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion. [1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab. |
| OG003 | Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion. [1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept. |
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