Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGAdalimumab
40 mg injection of adalimumab administered subcutaneously
1.0 ml .9% saline placebo administered subcutaneously
DRUGEtanercept
50 mg dimeric fusion protein administered subcutaneously
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly. 2. Leflunomide - maximum dose of 20 mg PO daily. 3. Sulfasalazine - maximum dose of 1,500 mg PO twice daily. 4. Hydroxychloroquine - maximum dose of 400 mg PO daily. * 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
* Diagnosis of another autoimmune disease likely to require immunosuppression. More information on this criterion can be found in the protocol. * Failing treatment with etanercept if previously treated with adalimumab * Failing treatment with adalimumab if previously treated with etanercept * Intraarticular injection within 4 weeks prior to randomization * Concomitant use of DMARDs other than those described in Inclusion Criteria within 12 weeks of randomization. * Concurrent use of any biologic agent other than etanercept or adalimumab * Concomitant immunosuppressive therapy other than the Disease-Modifying Anti-Rheumatic Drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), or corticosteroids specified in the protocol * Presence of open leg ulcers * Chronic or persistent infection that may be worsened by immunosuppressive treatment. More information on this criterion can be found in the protocol. * Active infection or severe infections requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 30 days prior to randomization * History of positive Purified Protein Derivative (PPD) or chest x-ray findings indicative of prior tuberculosis infection * Any medical condition or treatment that, in the opinion of the investigator, would put the subject at risk by participation in the study * History of malignancy. More information on this criterion can be found in the protocol. * Certain abnormal laboratory values. More information on this criterion can be found in the protocol. * Investigational biological or chemical agents within 4 weeks prior to randomization. * History of drug or alcohol abuse within a year prior to randomization * Treatment with natalizumab, rituximab, or another B-cell depleting therapy within a year prior to randomization * Treatment with infliximab, abatacept, tocilizumab, golimumab, or certolizumab pegol within 12 weeks prior to randomization. * Known allergy or hypersensitivity to study products * Any psychiatric disorder that prevents the participant from providing informed consent * Inability to follow protocol instructions * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. | Baseline, 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). |
| Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | Baseline, 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline, Week 12 | The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28\[CRP\] value of ≥ 1.2. |
| Participants With an ACR 20 Response at Week 12 | 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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP) |
| Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 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). |
| Participants With an ACR 70 Response at Week 12 | 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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP) |
| Participants With an ACR 50 Response at Week 12 | 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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP) |
| Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Each subject signed an informed consent prior to undergoing any screening procedures. At the screening visit, subjects underwent procedures to establish inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 4 |
| 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. | 4 |
| 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. | 2 |
| Total | 13 |
Baseline characteristics
| Characteristic | Non-Switcher/Adalimumab Alternating With Placebo | Non-Switcher/Etanercept | Switcher/Adalimumab to Etanercept | Switcher/Etanercept to Adalimumab Alternating With Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 11 Participants |
| Age Continuous | 53 years STANDARD_DEVIATION 4 | 65 years STANDARD_DEVIATION 9.4 | 39 years STANDARD_DEVIATION 13.7 | 60 years STANDARD_DEVIATION 6.4 | 53 years STANDARD_DEVIATION 14 |
| Disease Activity Score Using C-reactive Protein (DAS28[CRP]) | 5.6 Scores on a scale STANDARD_DEVIATION 0.66 | 5.4 Scores on a scale STANDARD_DEVIATION 0.44 | 4.8 Scores on a scale STANDARD_DEVIATION 0.62 | 5.3 Scores on a scale STANDARD_DEVIATION 0.19 | 5.3 Scores on a scale STANDARD_DEVIATION 0.56 |
| Region of Enrollment United States | 3 participants | 4 participants | 4 participants | 2 participants | 13 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 4 | 4 / 4 | 2 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 2 |
Outcome results
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).
Time frame: Baseline, Week 12
Population: Intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | -2.0 Scores on a scale | Standard Deviation 0.22 |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | -0.9 Scores on a scale | Standard Deviation 0.92 |
| Switcher/Adalimumab to Etanercept | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | -1.7 Scores on a scale | Standard Deviation 0.94 |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12. | -1.5 Scores on a scale | Standard Deviation 1.81 |
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).
Time frame: Baseline, Week 12
Population: Intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. | -1.4 Scores on a scale | Standard Deviation 0.9 |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. | -1.7 Scores on a scale | Standard Deviation 1.09 |
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.
Time frame: Baseline, Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | 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) | 3 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | 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) | 1 participants |
| Switcher/Adalimumab to Etanercept | 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) | 2 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | 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) | 1 participants |
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).
Time frame: Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 0 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 0 participants |
| Switcher/Adalimumab to Etanercept | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 1 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12 | 1 participants |
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).
Time frame: Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 1 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 1 participants |
| Switcher/Adalimumab to Etanercept | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 2 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12 | 1 participants |
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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP)
Time frame: Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Participants With an ACR 20 Response at Week 12 | 3 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Participants With an ACR 20 Response at Week 12 | 2 participants |
| Switcher/Adalimumab to Etanercept | Participants With an ACR 20 Response at Week 12 | 3 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants With an ACR 20 Response at Week 12 | 1 participants |
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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP)
Time frame: Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Participants With an ACR 50 Response at Week 12 | 2 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Participants With an ACR 50 Response at Week 12 | 0 participants |
| Switcher/Adalimumab to Etanercept | Participants With an ACR 50 Response at Week 12 | 1 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants With an ACR 50 Response at Week 12 | 0 participants |
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: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (CRP)
Time frame: Week 12
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Switcher/ Adalimumab or Etanercept | Participants With an ACR 70 Response at Week 12 | 0 participants |
| Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma | Participants With an ACR 70 Response at Week 12 | 0 participants |
| Switcher/Adalimumab to Etanercept | Participants With an ACR 70 Response at Week 12 | 0 participants |
| Switcher/Etanercept to Adalimumab Alternating With Placebo | Participants With an ACR 70 Response at Week 12 | 0 participants |