Trial record 1 of 1 for:    NCT00837434
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Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00837434
First received: February 3, 2009
Last updated: April 10, 2015
Last verified: April 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept
Drug: Adalimumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were to be recruited from seven sites in the United States. Recruitment occurred at six sites. The first site was activated in April 2009. The first participant was randomized in July 2009 and the last participant was randomized in July 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Etanercept Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Adalimumab Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.

Participant Flow:   Overall Study
    Etanercept     Adalimumab  
STARTED     43     20  
COMPLETED     34     19  
NOT COMPLETED     9     1  
Physician Decision                 3                 0  
Lost to Follow-up                 1                 1  
Withdrawn by sponsor/regulatory agency                 1                 0  
Noncompliant                 2                 0  
Baseline assessments not done in time                 1                 0  
Unable to obtain study drug                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either etanercept or adalimumab.

Reporting Groups
  Description
Etanercept Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Adalimumab Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Etanercept     Adalimumab     Total  
Number of Participants  
[units: participants]
  39     19     58  
Age  
[units: years]
Mean (Standard Deviation)
  51.7  (9.4)     52.7  (14.0)     52.0  (11.0)  
Gender  
[units: participants]
     
Female     31     15     46  
Male     8     4     12  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     8     1     9  
Not Hispanic or Latino     31     18     49  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     1     6  
White     30     18     48  
More than one race     0     0     0  
Unknown or Not Reported     4     0     4  
Region of Enrollment  
[units: participants]
     
United States     39     19     58  
Detection of Either IgM-Rheumatoid Factor or Antibodies to Cyclic Citrullinated Peptide [1]
[units: participants]
     
Positive     30     14     44  
Negative     9     5     14  
Detection of IgM-Rheumatoid Factor (IgM RF) [2]
[units: participants]
     
Positive     24     9     33  
Negative     15     10     25  
Detection of Antibodies to Cyclic Citrullinated Antibody Peptide [3]
[units: participants]
     
Positive     25     11     36  
Negative     14     8     22  
Methotrexate Dosage [4]
[units: mg]
Mean (Standard Deviation)
  17.4  (4.0)     18.8  (3.8)     17.9  (3.9)  
Years with Rheumatoid Arthritis [5]
[units: years]
Mean (Standard Deviation)
  5.8  (7.7)     4.3  (5.2)     5.3  (7.0)  
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [6]
[units: scores on a scale]
Mean (Standard Deviation)
  1.4  (0.7)     1.3  (0.6)     1.4  (0.7)  
C-reactive Protein (CRP) Level [7]
[units: mg/L]
Mean (Standard Deviation)
  14.1  (25.5)     13.3  (24.3)     13.8  (24.9)  
Tender Joint Count [8]
[units: Joints]
Mean (Standard Deviation)
  12.2  (6.6)     12.6  (7.2)     12.3  (6.7)  
Swollen Joint Count at Baseline [9]
[units: Joints]
Mean (Standard Deviation)
  9.9  (6.2)     9.4  (5.9)     9.7  (6.0)  
Patient’s Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) [10]
[units: cm]
Mean (Standard Deviation)
  5.9  (2.6)     7.3  (2.0)     6.4  (2.5)  
Disease Activity Score Using C-reactive Protein (DAS28-CRP) [11]
[units: scores on a scale]
Mean (Standard Deviation)
  5.2  (1.0)     5.4  (0.7)     5.3  (0.9)  
[1] Serum IgM-Rheumatoid Factor (IgM RF) is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage. Antibodies to Cyclic Citrullinated Peptide (anti-CCP) is often detected in in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.
[2] Serum IgM RF is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage.
[3] Anti-CCP is often present in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.
[4] Participants were required to be on a stable dose of methotrexate to be enrolled in the study. Stable dose definition: between 7.5 mg and 25 mg by mouth or subcutaneously weekly for at least 8 weeks prior to randomization.
[5] Years since diagnosis of rheumatoid arthritis by a physician. Participants were required to be diagnosed with Rheumatoid Arthritis at least 3 months before enrolling in the study.
[6] HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker, or help is received from another person in the daily living activities. Scores from each of the 8 categories are totaled and can range from 0 to 24.
[7] CRP is an acute phase reactant that is used to identify the presence of nonspecific inflammation. The CRP normal reference range depends on the laboratory. In this study the upper limit of normal ranged from 4 to 10.9 mg/L. An increased CRP level indicated the presence of inflammation. A low CRP may mean an absence of inflammation.
[8] Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints examined. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness.
[9] Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints examined. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling.
[10] A self-reported measure of perceived disease activity obtained by responding to the question "considering all the ways that your arthritis affects you, rate how you are doing on the following scale by placing a vertical mark." A vertical mark on a 10 cm line rated 0 (very well) to 10 (very bad) determines the score. The range: 0 to 10, with 10 being severe symptoms).
[11] The DAS28 is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein (CRP) in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).



  Outcome Measures
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1.  Primary:   Percentage of CD27+ Switched Memory B Cells at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants Fulfilling DAS-28-CRP “Good or Moderate Response” Criteria at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Percentage of Participants Meeting ACR20 Response Criteria at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   Percentage of Participants Meeting ACR20 Response Criteria at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Percentage of Participants Meeting ACR50 Response Criteria at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Percentage of Participants Meeting ACR50 Response Criteria at Week 24   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00837434     History of Changes
Other Study ID Numbers: DAIT ARA06
Study First Received: February 3, 2009
Results First Received: March 18, 2015
Last Updated: April 10, 2015
Health Authority: United States: Federal Government