Trial Outcomes & Findings for Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (NCT NCT00794118)
NCT ID: NCT00794118
Last Updated: 2019-07-01
Results Overview
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.
COMPLETED
299 participants
Month 3
2019-07-01
Participant Flow
Participant milestones
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
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 Study
STARTED
|
299
|
|
Overall Study
COMPLETED
|
272
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
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 Study
Lost to Follow-up
|
16
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Changed hospital center
|
2
|
Baseline Characteristics
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Baseline characteristics by cohort
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=299 Participants
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.
|
|---|---|
|
Age, Customized
18 to 34 years
|
29 Participants
n=5 Participants
|
|
Age, Customized
35 to 49 years
|
72 Participants
n=5 Participants
|
|
Age, Customized
50 to 64 years
|
133 Participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission
|
1.7 Percentage of participants
n=5 Participants
|
|
Disease Activity Score Based on 28-joints count (DAS28)
|
5.4 Units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Patient Global Assessment (PtGA)
|
6.6 centimeter (cm)
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Physician Global Assessment (PGA)
|
6.1 cm
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Visual Analogue Scale for Pain (VAS-pain)
|
6.7 cm
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
C-reactive Protein (CRP)
|
3.3 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Erythrocyte Sedimentation Rate (ESR)
|
32.9 millimeter/hour (mm/hr)
STANDARD_DEVIATION 22.0 • n=5 Participants
|
|
Rheumatoid Factor (RF)
Positive
|
163 Participants
n=5 Participants
|
|
Rheumatoid Factor (RF)
Negative
|
118 Participants
n=5 Participants
|
|
Rheumatoid Factor (RF)
Not available (NA)
|
18 Participants
n=5 Participants
|
|
Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies
Positive
|
124 Participants
n=5 Participants
|
|
Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies
Negative
|
97 Participants
n=5 Participants
|
|
Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies
NA
|
78 Participants
n=5 Participants
|
|
Anti-nuclear antibodies
Positive
|
38 Participants
n=5 Participants
|
|
Anti-nuclear antibodies
Negative
|
170 Participants
n=5 Participants
|
|
Anti-nuclear antibodies
NA
|
91 Participants
n=5 Participants
|
|
Anti-deoxyribonucleic Acid (Anti-DNA) antibodies
Positive
|
6 Participants
n=5 Participants
|
|
Anti-deoxyribonucleic Acid (Anti-DNA) antibodies
Negative
|
173 Participants
n=5 Participants
|
|
Anti-deoxyribonucleic Acid (Anti-DNA) antibodies
NA
|
120 Participants
n=5 Participants
|
|
Duration of morning stiffness
|
61.8 minutes
STANDARD_DEVIATION 48.0 • n=5 Participants
|
|
Stanford Health Assessment Questionnaire (HAQ)
|
1.4 Units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
36-Item Short-Form Health Survey (SF-36)
Indice sintetico salute fisica del (ISF)
|
38.8 Units on a Scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
36-Item Short-Form Health Survey (SF-36)
Indice sintetico salute mentale del (ISM)
|
48.0 Units on a Scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Disease duration
|
5.0 Years
n=5 Participants
|
|
Number of tender joints
|
11.0 Tender joints
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Number of swollen joints (SJC)
|
7.3 Swollen joints
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD)
|
98.3 Percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
|
13.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
|
21.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
|
27.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12Population: 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).
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
|
22.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
|
4.2 Units on a Scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
|
3.7 Units on a Scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
|
3.4 Units on a Scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
|
3.6 Units on a Scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
|
4.1 cm
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
|
3.4 cm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
|
2.8 cm
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
|
3.3 cm
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Physician Global Assessment (PGA) of Disease Activity at Month 3
|
3.7 cm
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Physician Global Assessment (PGA) of Disease Activity at Month 6
|
2.9 cm
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Physician Global Assessment (PGA) of Disease Activity at Month 9
|
2.3 cm
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Physician Global Assessment (PGA) of Disease Activity at Month 12
|
2.8 cm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 3
|
4.1 cm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 6
|
3.3 cm
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 9
|
2.9 cm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 12
|
3.3 cm
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
C-reactive Protein (CRP) at Month 3
|
1.4 mg/dL
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
C-reactive Protein (CRP) at Month 6
|
1.3 mg/dL
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
C-reactive Protein (CRP) at Month 9
|
1.1 mg/dL
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
C-reactive Protein (CRP) at Month 12
|
1.5 mg/dL
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Month 3
|
23.9 mm/hr
Standard Deviation 18.8
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Month 6
|
20.8 mm/hr
Standard Deviation 16.2
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Month 9
|
18.4 mm/hr
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Month 12
|
21.9 mm/hr
Standard Deviation 18.9
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Rheumatoid Factor (RF) at Month 3
Positive
|
80 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 3
Negative
|
88 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 3
NA
|
98 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Rheumatoid Factor (RF) at Month 6
Positive
|
77 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 6
Negative
|
74 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 6
NA
|
83 Participants
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Rheumatoid Factor (RF) at Month 9
Positive
|
63 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 9
Negative
|
57 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 9
NA
|
106 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Rheumatoid Factor (RF) at Month 12
Positive
|
88 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 12
Negative
|
67 Participants
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 12
NA
|
117 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Positive
|
43 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Negative
|
50 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
NA
|
174 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Positive
|
44 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Negative
|
44 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
NA
|
147 Participants
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Positive
|
32 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Negative
|
39 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
NA
|
154 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Positive
|
52 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Negative
|
45 Participants
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
NA
|
175 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-nuclear Antibodies at Month 3
Positive
|
8 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 3
Negative
|
78 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 3
NA
|
181 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-nuclear Antibodies at Month 6
Positive
|
14 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 6
Negative
|
79 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 6
NA
|
142 Participants
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-nuclear Antibodies at Month 9
Positive
|
9 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 9
Negative
|
57 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 9
NA
|
159 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-nuclear Antibodies at Month 12
Negative
|
85 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 12
Positive
|
14 Participants
|
|
Number of Participants With Anti-nuclear Antibodies at Month 12
NA
|
173 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Positive
|
1 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Negative
|
79 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
NA
|
187 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Positive
|
1 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Negative
|
80 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
NA
|
154 Participants
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Positive
|
4 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Negative
|
60 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
NA
|
161 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Positive
|
3 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Negative
|
88 Participants
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
NA
|
181 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Duration of Morning Stiffness at Month 3
|
26.4 minutes
Standard Deviation 26.3
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Duration of Morning Stiffness at Month 6
|
19.6 minutes
Standard Deviation 32.7
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Duration of Morning Stiffness at Month 9
|
13.2 minutes
Standard Deviation 17.5
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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.
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Duration of Morning Stiffness at Month 12
|
17.8 minutes
Standard Deviation 23.8
|
PRIMARY outcome
Timeframe: Month 3Population: ITT population included all participants who received at least 1 dose of the study medication.
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).
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
|
1.0 Units on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Month 6Population: ITT population included all participants who received at least 1 dose of the study medication.
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).
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
|
0.7 Units on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Month 9Population: ITT population included all participants who received at least 1 dose of the study medication.
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).
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
|
0.7 Units on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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).
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
|
0.8 Units on a Scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Month 12Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
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).
Outcome measures
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 Participants
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.
|
|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Month 12
ISF
|
52.2 Units on a Scale
Standard Deviation 14.7
|
|
36-Item Short-Form Health Survey (SF-36) at Month 12
ISM
|
55.5 Units on a Scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9 and 12Population: There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.
Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9 and 12Population: There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
Outcome measures
Outcome data not reported
Adverse Events
Anti-tumor Necrosis Factor (Anti-TNF) Agents
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anti-tumor Necrosis Factor (Anti-TNF) Agents
n=272 participants at risk
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.
|
|---|---|
|
Immune system disorders
Infusion related reaction
|
4.8%
13/272
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary infection
|
1.1%
3/272
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.
|
|
General disorders
Injection site reaction
|
0.74%
2/272
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.
|
|
Vascular disorders
Blood pressure high
|
0.37%
1/272
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.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.37%
1/272
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.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.37%
1/272
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER