Trial Outcomes & Findings for Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis (NCT NCT01078155)
NCT ID: NCT01078155
Last Updated: 2015-06-26
Results Overview
BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.
Recruitment status
COMPLETED
Target enrollment
131 participants
Primary outcome timeframe
Baseline (Day 0), Month 12, Month 24
Results posted on
2015-06-26
Participant Flow
Participant milestones
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant's enrollment in the study.
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|---|---|
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Overall Study
STARTED
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131
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Overall Study
COMPLETED
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87
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Overall Study
NOT COMPLETED
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44
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Reasons for withdrawal
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant's enrollment in the study.
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|---|---|
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Overall Study
Adverse Event
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7
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Overall Study
Lack of Efficacy
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16
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Overall Study
Participant's Decision
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6
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Overall Study
Lost to Follow-up
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15
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Baseline Characteristics
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=131 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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123 Participants
n=5 Participants
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Age, Categorical
>=65 years
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8 Participants
n=5 Participants
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Sex: Female, Male
Female
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116 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
L1-L4 BMD: Baseline; n=86
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1.06 g/cm^2
Standard Deviation 0.15
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
L1-L4 BMD: Month 12; n=71
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1.07 g/cm^2
Standard Deviation 0.17
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
L1-L4 BMD: Month 24; n=59
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1.06 g/cm^2
Standard Deviation 0.17
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
Proximal Femur BMD: Baseline; n=86
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0.88 g/cm^2
Standard Deviation 0.14
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
Proximal Femur BMD: Month 12; n=72
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0.91 g/cm^2
Standard Deviation 0.13
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Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
Proximal Femur BMD: Month 24; n=58
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0.90 g/cm^2
Standard Deviation 0.13
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; \< -1 and \> -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 T-score: Baseline; n=85
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-0.57 standard deviations
Standard Deviation 1.14
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 T-score: Month 12; n=71
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-0.42 standard deviations
Standard Deviation 1.15
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 T-score: Month 24; n=58
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-0.40 standard deviations
Standard Deviation 1.15
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 Z-score: Baseline; n=82
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-0.02 standard deviations
Standard Deviation 1.14
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 Z-score: Month 12; n=67
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0.15 standard deviations
Standard Deviation 1.08
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
L1-L4 Z-score: Month 24; n=54
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0.21 standard deviations
Standard Deviation 1.09
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur T-score: Baseline; n=85
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-0.70 standard deviations
Standard Deviation 1.11
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur T-score: Month 12; n=72
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-0.60 standard deviations
Standard Deviation 0.97
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur T-score: Month 24; n=55
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-0.68 standard deviations
Standard Deviation 1.03
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur Z-score: Baseline; n=82
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-0.18 standard deviations
Standard Deviation 1.05
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur Z-score: Month 12; n=68
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-0.10 standard deviations
Standard Deviation 0.96
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Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Proximal Femur Z-score: Month 24; n=52
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-0.14 standard deviations
Standard Deviation 1.04
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 12; n=9
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-2.21 µg/L
Standard Deviation 11.99
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Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 24; n=5
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1.39 µg/L
Standard Deviation 8.77
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Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 3; n=6
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-2.97 µg/L
Standard Deviation 4.68
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 3; n=8
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8.70 ng/mL
Standard Deviation 17.78
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Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 12; n=11
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-1.87 ng/mL
Standard Deviation 17.22
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Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 24; n=7
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15.29 ng/mL
Standard Deviation 21.18
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 12; n=14
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0.06 µg/L
Standard Deviation 0.46
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Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 24; n=11
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-0.01 µg/L
Standard Deviation 0.28
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Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
Baseline - Month 3; n=14
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-0.01 µg/L
Standard Deviation 0.09
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
Participant-reported the existence and duration of morning stiffness, defined as "morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Baseline; n=84
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95.0 minutes
Standard Deviation 58.34
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Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Month 3; n=60
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37.5 minutes
Standard Deviation 42.48
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Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Month 12; n=51
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27.7 minutes
Standard Deviation 34.63
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Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Month 24; n=53
|
25.8 minutes
Standard Deviation 27.27
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PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
Baseline; n=87
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14.3 joints
Standard Deviation 6.52
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Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 3; n=87
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3.1 joints
Standard Deviation 3.01
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Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 12; n=87
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1.9 joints
Standard Deviation 2.39
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Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 24; n=84
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1.7 joints
Standard Deviation 1.88
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SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
Baseline; n=87
|
9.5 joints
Standard Deviation 4.91
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Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 3; n=87
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2.3 joints
Standard Deviation 2.76
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Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 12; n=87
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1.0 joints
Standard Deviation 1.57
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Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
Month 24; n=84
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1.0 joints
Standard Deviation 1.22
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SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Baseline; n=87
|
6.24 units on a scale
Standard Deviation 0.73
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Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Month 3; n=87
|
3.55 units on a scale
Standard Deviation 1.13
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Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Month 12; n=85
|
2.86 units on a scale
Standard Deviation 1.04
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Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Month 24; n=75
|
2.83 units on a scale
Standard Deviation 0.93
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SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.
Physician's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=86 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Baseline
|
68.0 units on a scale
Standard Deviation 11.77
|
|
Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 3
|
29.7 units on a scale
Standard Deviation 16.69
|
|
Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 12
|
23.0 units on a scale
Standard Deviation 15.50
|
|
Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 24
|
21.5 units on a scale
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
Subject's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Baseline; n=86
|
71.1 units on a scale
Standard Deviation 12.36
|
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Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 3; n=86
|
31.4 units on a scale
Standard Deviation 16.18
|
|
Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 12; n=85
|
24.7 units on a scale
Standard Deviation 15.18
|
|
Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Month 24; n=85
|
24.0 units on a scale
Standard Deviation 14.37
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
Subject's Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Baseline; n=86
|
71.3 units on a scale
Standard Deviation 12.38
|
|
Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Month 3; n=86
|
29.4 units on a scale
Standard Deviation 14.33
|
|
Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Month 12; n=85
|
25.8 units on a scale
Standard Deviation 16.56
|
|
Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Month 24; n=85
|
24.2 units on a scale
Standard Deviation 15.51
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Month 3, Month 12, Month 24Population: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.
ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.
Outcome measures
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=87 Participants
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
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Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
Baseline; n=65
|
37.77 mm/1 hour
Standard Deviation 21.06
|
|
Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
Month 3; n=64
|
17.97 mm/1 hour
Standard Deviation 14.91
|
|
Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
Month 12; n=65
|
17.15 mm/1 hour
Standard Deviation 14.13
|
|
Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
Month 24; n=63
|
17.67 mm/1 hour
Standard Deviation 12.34
|
Adverse Events
Participants With Active Rheumatoid Arthritis (RA)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=131 participants at risk
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
Other adverse events
| Measure |
Participants With Active Rheumatoid Arthritis (RA)
n=131 participants at risk
Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.
|
|---|---|
|
Immune system disorders
Dermatitis Allergic
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Infections and infestations
Bronchitis
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Infections and infestations
Urinary Tract Infection
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Infections and infestations
Viral Infection
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Nervous system disorders
Headache
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Skin and subcutaneous tissue disorders
Cutaneous Vasculitis
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.76%
1/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.5%
2/131 • 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).
|
Additional Information
Global Medical Information
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER