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Trial record 1 of 1 for:    NCT00794118
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Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (DOSE)

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ClinicalTrials.gov Identifier: NCT00794118
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : May 16, 2012
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Other: As per clinical practice
Enrollment 299
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Period Title: Overall Study
Started 299
Completed 272
Not Completed 27
Reason Not Completed
Lost to Follow-up             16
Withdrawal by Subject             9
Changed hospital center             2
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Baseline Participants 299
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants
18 to 34 years 29
35 to 49 years 72
50 to 64 years 133
Greater than or equal to (>=) 65 years 65
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants
Female
230
  76.9%
Male
69
  23.1%
Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 299 participants
1.7
[1]
Measure Description: DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
Disease Activity Score Based on 28-joints count (DAS28)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 299 participants
5.4  (1.2)
[1]
Measure Description: DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Number of participants analyzed (N)=272 for this parameter.
Patient Global Assessment (PtGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 299 participants
6.6  (2.1)
[1]
Measure Description: PtGA measured using a 10 cm Visual Analog Scale (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Physician Global Assessment (PGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 299 participants
6.1  (1.7)
[1]
Measure Description: PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Visual Analogue Scale for Pain (VAS-pain)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 299 participants
6.7  (2.2)
[1]
Measure Description: 10 cm line (VAS) marked by participant. Intensity of pain range: 0 cm = no pain to 10 cm = worst possible pain.
C-reactive Protein (CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Milligram/deciliter (mg/dL)
Number Analyzed 299 participants
3.3  (6.3)
[1]
Measure Description: CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. Number of participants analyzed (N) = 272 for this parameter.
Erythrocyte Sedimentation Rate (ESR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeter/hour (mm/hr)
Number Analyzed 299 participants
32.9  (22.0)
[1]
Measure Description: ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Rheumatoid Factor (RF)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants
Positive 163
Negative 118
Not available (NA) 18
[1]
Measure Description: RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 unit/milliliter (U/mL) is considered positive.
Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants
Positive 124
Negative 97
NA 78
[1]
Measure Description: Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Anti-nuclear antibodies   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants
Positive 38
Negative 170
NA 91
[1]
Measure Description: Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Anti-deoxyribonucleic Acid (Anti-DNA) antibodies   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 299 participants
Positive 6
Negative 173
NA 120
[1]
Measure Description: Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Duration of morning stiffness   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 299 participants
61.8  (48.0)
[1]
Measure Description: Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Stanford Health Assessment Questionnaire (HAQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 299 participants
1.4  (0.7)
[1]
Measure Description: HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Average score range: 0 to 3.
36-Item Short-Form Health Survey (SF-36)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 299 participants
Indice sintetico salute fisica del (ISF) 38.8  (10.6)
Indice sintetico salute mentale del (ISM) 48.0  (13.2)
[1]
Measure Description: SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Disease duration  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 299 participants
5.0
(2.0 to 10.0)
Number of tender joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender joints
Number Analyzed 299 participants
11.0  (7.1)
[1]
Measure Description: The mean number of tender joints was evaluated based on the number of tender joints in a standard 28 joint count.
Number of swollen joints (SJC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Swollen joints
Number Analyzed 299 participants
7.3  (5.3)
[1]
Measure Description: The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 28 joint count.
Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD)  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 299 participants
98.3
1.Primary Outcome
Title Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Percentage of participants
13.4
2.Primary Outcome
Title Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Percentage of participants
21.6
3.Primary Outcome
Title Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Percentage of participants
27.2
4.Primary Outcome
Title Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Percentage of participants
22.6
5.Primary Outcome
Title Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
4.2  (1.3)
6.Primary Outcome
Title Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
3.7  (1.3)
7.Primary Outcome
Title Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
3.4  (1.2)
8.Primary Outcome
Title Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
Hide Description DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
3.6  (1.5)
9.Primary Outcome
Title Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
Hide Description PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
4.1  (2.3)
10.Primary Outcome
Title Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
Hide Description PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
3.4  (2.4)
11.Primary Outcome
Title Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
Hide Description PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
2.8  (2.3)
12.Primary Outcome
Title Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
Hide Description PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
3.3  (2.6)
13.Primary Outcome
Title Physician Global Assessment (PGA) of Disease Activity at Month 3
Hide Description PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
3.7  (2.1)
14.Primary Outcome
Title Physician Global Assessment (PGA) of Disease Activity at Month 6
Hide Description PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
2.9  (2.1)
15.Primary Outcome
Title Physician Global Assessment (PGA) of Disease Activity at Month 9
Hide Description PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
2.3  (2.1)
16.Primary Outcome
Title Physician Global Assessment (PGA) of Disease Activity at Month 12
Hide Description PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
2.8  (2.4)
17.Primary Outcome
Title Visual Analogue Scale for Pain (VAS-pain) at Month 3
Hide Description 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
4.1  (2.4)
18.Primary Outcome
Title Visual Analogue Scale for Pain (VAS-pain) at Month 6
Hide Description 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
3.3  (2.3)
19.Primary Outcome
Title Visual Analogue Scale for Pain (VAS-pain) at Month 9
Hide Description 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
2.9  (2.4)
20.Primary Outcome
Title Visual Analogue Scale for Pain (VAS-pain) at Month 12
Hide Description 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: cm
3.3  (2.7)
21.Primary Outcome
Title C-reactive Protein (CRP) at Month 3
Hide Description CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.4  (2.5)
22.Primary Outcome
Title C-reactive Protein (CRP) at Month 6
Hide Description CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.3  (2.5)
23.Primary Outcome
Title C-reactive Protein (CRP) at Month 9
Hide Description CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.1  (1.6)
24.Primary Outcome
Title C-reactive Protein (CRP) at Month 12
Hide Description CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.5  (2.6)
25.Primary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Month 3
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mm/hr
23.9  (18.8)
26.Primary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Month 6
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mm/hr
20.8  (16.2)
27.Primary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Month 9
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mm/hr
18.4  (13.5)
28.Primary Outcome
Title Erythrocyte Sedimentation Rate (ESR) at Month 12
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: mm/hr
21.9  (18.9)
29.Primary Outcome
Title Number of Participants With Rheumatoid Factor (RF) at Month 3
Hide Description RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 80
Negative 88
NA 98
30.Primary Outcome
Title Number of Participants With Rheumatoid Factor (RF) at Month 6
Hide Description RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 77
Negative 74
NA 83
31.Primary Outcome
Title Number of Participants With Rheumatoid Factor (RF) at Month 9
Hide Description RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 63
Negative 57
NA 106
32.Primary Outcome
Title Number of Participants With Rheumatoid Factor (RF) at Month 12
Hide Description RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 88
Negative 67
NA 117
33.Primary Outcome
Title Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Hide Description Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 43
Negative 50
NA 174
34.Primary Outcome
Title Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Hide Description Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 44
Negative 44
NA 147
35.Primary Outcome
Title Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Hide Description Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 32
Negative 39
NA 154
36.Primary Outcome
Title Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Hide Description Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 52
Negative 45
NA 175
37.Primary Outcome
Title Number of Participants With Anti-nuclear Antibodies at Month 3
Hide Description Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 8
Negative 78
NA 181
38.Primary Outcome
Title Number of Participants With Anti-nuclear Antibodies at Month 6
Hide Description Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 14
Negative 79
NA 142
39.Primary Outcome
Title Number of Participants With Anti-nuclear Antibodies at Month 9
Hide Description Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 9
Negative 57
NA 159
40.Primary Outcome
Title Number of Participants With Anti-nuclear Antibodies at Month 12
Hide Description Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 14
Negative 85
NA 173
41.Primary Outcome
Title Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Hide Description Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 1
Negative 79
NA 187
42.Primary Outcome
Title Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Hide Description Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 1
Negative 80
NA 154
43.Primary Outcome
Title Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Hide Description Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 4
Negative 60
NA 161
44.Primary Outcome
Title Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Hide Description Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Measure Type: Number
Unit of Measure: Participants
Positive 3
Negative 88
NA 181
45.Primary Outcome
Title Duration of Morning Stiffness at Month 3
Hide Description Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: minutes
26.4  (26.3)
46.Primary Outcome
Title Duration of Morning Stiffness at Month 6
Hide Description Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: minutes
19.6  (32.7)
47.Primary Outcome
Title Duration of Morning Stiffness at Month 9
Hide Description Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: minutes
13.2  (17.5)
48.Primary Outcome
Title Duration of Morning Stiffness at Month 12
Hide Description Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: minutes
17.8  (23.8)
49.Primary Outcome
Title Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
Hide Description HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
1.0  (0.7)
50.Primary Outcome
Title Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
Hide Description HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.7  (0.7)
51.Primary Outcome
Title Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
Hide Description HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time Frame Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.7  (0.7)
52.Primary Outcome
Title Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
Hide Description HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.8  (0.7)
53.Primary Outcome
Title 36-Item Short-Form Health Survey (SF-36) at Month 12
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
ISF 52.2  (14.7)
ISM 55.5  (11.8)
54.Secondary Outcome
Title Direct Costs
Hide Description Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
Time Frame Baseline, Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
55.Secondary Outcome
Title Indirect Costs
Hide Description Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
Time Frame Baseline, Months 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Anti-tumor Necrosis Factor (Anti-TNF) Agents
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
All-Cause Mortality
Anti-tumor Necrosis Factor (Anti-TNF) Agents
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Anti-tumor Necrosis Factor (Anti-TNF) Agents
Affected / at Risk (%)
Total   0/272 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-tumor Necrosis Factor (Anti-TNF) Agents
Affected / at Risk (%)
Total   21/272 (7.72%) 
Gastrointestinal disorders   
Mucositis oral * 1  1/272 (0.37%) 
General disorders   
Injection site reaction * 1  2/272 (0.74%) 
Immune system disorders   
Infusion related reaction * 1  13/272 (4.78%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary infection * 1  3/272 (1.10%) 
Skin and subcutaneous tissue disorders   
Angioedema * 1  1/272 (0.37%) 
Vascular disorders   
Blood pressure high * 1  1/272 (0.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00794118    
Other Study ID Numbers: 0881A1-102321
B1801119
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: April 12, 2012
Results First Posted: May 16, 2012
Last Update Posted: July 1, 2019