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Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT00796705
Recruitment Status : Terminated (Lack of Enrollment)
First Posted : November 24, 2008
Results First Posted : August 13, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Adalimumab
Drug: Adalimumab placebo
Drug: Etanercept
Enrollment 13
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.
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 3 4 4 2
Completed 3 4 4 2
Not Completed 0 0 0 0
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 3 4 4 2 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 2 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
2
  50.0%
4
 100.0%
2
 100.0%
11
  84.6%
>=65 years
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
2
  15.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 4 participants 2 participants 13 participants
53  (4.0) 65  (9.4) 39  (13.7) 60  (6.4) 53  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 4 participants 2 participants 13 participants
Female
3
 100.0%
4
 100.0%
4
 100.0%
2
 100.0%
13
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 4 participants 2 participants 13 participants
3 4 4 2 13
Disease Activity Score Using C-reactive Protein (DAS28[CRP])   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 3 participants 4 participants 4 participants 2 participants 13 participants
5.6  (0.66) 5.4  (0.44) 4.8  (0.62) 5.3  (0.19) 5.3  (0.56)
[1]
Measure Description: 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).
1.Primary Outcome
Title Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.
Hide Description 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
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Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/ Adalimumab or Etanercept Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma
Hide Arm/Group Description:

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 and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) 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.
  2. 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.

Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg 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. 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.
  2. 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.
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.4  (0.90) -1.7  (1.09)
2.Primary Outcome
Title Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.0  (0.22) -0.9  (0.92) -1.7  (0.94) -1.5  (1.81)
3.Secondary Outcome
Title Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
1 1 2 1
4.Secondary Outcome
Title Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
0 0 1 1
5.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
3 1 2 1
6.Secondary Outcome
Title Participants With an ACR 20 Response at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
3 2 3 1
7.Secondary Outcome
Title Participants With an ACR 50 Response at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
2 0 1 0
8.Secondary Outcome
Title Participants With an ACR 70 Response at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Non-Switcher/Adalimumab Alternating With Placebo Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab Alternating With Placebo
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 3 4 4 2
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-Switcher/Adalimumab Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab
Hide Arm/Group Description Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab Subjects failing Etanercept at screening who were randomized to remain on Etanercept Subjects failing Adalimumab at screening who were randomized to switch to Etanercept Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
All-Cause Mortality
Non-Switcher/Adalimumab Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Non-Switcher/Adalimumab Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-Switcher/Adalimumab Non-Switcher/Etanercept Switcher/Adalimumab to Etanercept Switcher/Etanercept to Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/4 (75.00%)      4/4 (100.00%)      2/2 (100.00%)    
Gastrointestinal disorders         
Abdominal distension  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Constipation  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  7
Dry mouth  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Nausea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
General disorders         
Fatigue  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Influenza like illness  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Injection site haematoma  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  1
Injection site irritation  1  0/3 (0.00%)  0 2/4 (50.00%)  6 0/4 (0.00%)  0 1/2 (50.00%)  1
Injection site pain  1  0/3 (0.00%)  0 2/4 (50.00%)  7 0/4 (0.00%)  0 0/2 (0.00%)  0
Injection site reaction  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Gastroenteritis viral  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Laryngitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Nasopharyngitis  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Otitis media  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Rhinitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Tooth abscess  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Upper respiratory tract infection  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Viral upper respiratory tract infection  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Injury, poisoning and procedural complications         
Excoriation  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Humerus fracture  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  1
Investigations         
Cardiac murmur  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Gallop rhythm present  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Haemoglobin decreased  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
White blood cell count decreased  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Hypoglycaemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  1
Hypokalaemia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/3 (33.33%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal pain  1  1/3 (33.33%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
Rheumatoid arthritis  1  1/3 (33.33%)  2 0/4 (0.00%)  0 1/4 (25.00%)  1 1/2 (50.00%)  1
Tendonitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Headache  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 1/2 (50.00%)  2
Respiratory, thoracic and mediastinal disorders         
Prolonged expiration  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/2 (50.00%)  1
Tonsillar hypertrophy  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash  1  0/3 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0 0/2 (0.00%)  0
Skin lesion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
The study terminated early due to recruitment feasibility issues. Thirteen subjects were enrolled and received treatment. No mechanistic analyses were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Associate Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00796705     History of Changes
Other Study ID Numbers: DAIT ARA05
First Submitted: November 20, 2008
First Posted: November 24, 2008
Results First Submitted: July 5, 2012
Results First Posted: August 13, 2012
Last Update Posted: October 4, 2012