Trial Outcomes & Findings for A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece (NCT NCT01086033)
NCT ID: NCT01086033
Last Updated: 2013-09-26
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.
COMPLETED
566 participants
3 years
2013-09-26
Participant Flow
Participant milestones
| Measure |
Humira
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
|---|---|
|
Overall Study
STARTED
|
566
|
|
Overall Study
COMPLETED
|
262
|
|
Overall Study
NOT COMPLETED
|
304
|
Reasons for withdrawal
| Measure |
Humira
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
|---|---|
|
Overall Study
Lack of efficacy/Exacerbation of RA
|
86
|
|
Overall Study
Lost to Follow-up
|
86
|
|
Overall Study
Adverse Event
|
42
|
|
Overall Study
Withdrawal by Subject
|
41
|
|
Overall Study
Other
|
13
|
|
Overall Study
AE and Withdrew Consent
|
5
|
|
Overall Study
Withdrew Consent and Lack of Efficacy
|
5
|
|
Overall Study
Withdrew consent and Other Reason
|
4
|
|
Overall Study
AE and Lack of Efficacy
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
AE and Lost to Follow-up
|
1
|
|
Overall Study
AE and Other Reason
|
1
|
|
Overall Study
AE, Withdrew Consent & Lack of Efficacy
|
1
|
Baseline Characteristics
A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece
Baseline characteristics by cohort
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
|---|---|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
456 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
566 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The safety population, including all patients that received at least one dose of the study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any Adverse Event
|
262 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Serious Adverse Event
|
65 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population; "n" indicates the number of participants with available data at each time point.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Disease Activity Score (DAS) 28 Over Time
Baseline (n=555)
|
6.0 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 3 (n=510)
|
4.2 units on a scale
Standard Deviation 1.4
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 6 (n=449)
|
3.8 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 9 (n=401)
|
3.5 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 12 (n=379)
|
3.5 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 18 (n=333)
|
3.3 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 24 (n=298)
|
3.2 units on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 30 (n=264)
|
3.0 units on a scale
Standard Deviation 1.4
|
—
|
—
|
|
Disease Activity Score (DAS) 28 Over Time
Month 36 (n=254)
|
2.9 units on a scale
Standard Deviation 1.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population;
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. A Moderate EULAR Response is defined as either: * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or * an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. No Response is defined as either: * an improvement (decrease) in the DAS28 of ≤ to 0.6, or * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1.
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
n=566 Participants
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
n=566 Participants
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
European League Against Rheumatism (EULAR) Response
Month 3 (n=501)
|
112 participants
|
242 participants
|
147 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 6 (n=443)
|
154 participants
|
193 participants
|
96 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 9 (n=394)
|
173 participants
|
147 participants
|
74 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 12 (n=373)
|
171 participants
|
139 participants
|
63 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 18 (n=327)
|
168 participants
|
105 participants
|
54 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 24 (n=294)
|
169 participants
|
84 participants
|
41 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 30 (n=262)
|
155 participants
|
78 participants
|
29 participants
|
|
European League Against Rheumatism (EULAR) Response
Month 36 (n=253)
|
156 participants
|
68 participants
|
29 participants
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR20 could be calculated at each time point.
American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 3 (n=491)
|
265 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 6 (n=427)
|
279 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 9 (n=384)
|
263 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 12 (n=363)
|
248 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 18 (n=330)
|
241 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 24 (n=293)
|
216 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 30 (n=259)
|
198 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response
Month 36 (n=248)
|
194 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR50 could be calculated at each time point.
American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 9 (n=388)
|
205 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 12 (n=368)
|
182 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 18 (n=333)
|
184 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 24 (n=291)
|
170 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 30 (n=256)
|
161 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 36 (n=250)
|
164 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 3 (n=498)
|
134 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response
Month 6 (n=433)
|
188 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR70 could be calculated at each time point.
American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 6 (n=435)
|
118 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 9 (n=390)
|
147 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 12 (n=373)
|
142 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 18 (n=330)
|
154 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 3 (n=495)
|
67 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 24 (n=294)
|
149 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 30 (n=261)
|
139 participants
|
—
|
—
|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response
Month 36 (n=253)
|
144 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12, 18, 24, 30, and 36Population: Safety population; "n" indicates the number of participants with available data at each time point.
Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.
Outcome measures
| Measure |
Humira
n=566 Participants
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
Moderate Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
|
No Response
Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
|
|---|---|---|---|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 6 (n=451)
|
8.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 9 (n=406)
|
7.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 12 (n=384)
|
7.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 18 (n=341)
|
8.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 24 (n=303)
|
7.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 30 (n=271)
|
5.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 36 (n=262)
|
4.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Who Missed at Least One Dose of Humira
Month 3 (n=512)
|
6.6 percentage of participants
|
—
|
—
|
Adverse Events
Humira
Serious adverse events
| Measure |
Humira
n=566 participants at risk
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.35%
2/566 • 3 years
|
|
Blood and lymphatic system disorders
Lymph nodes enlarged
|
0.18%
1/566 • 3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.18%
1/566 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
1/566 • 3 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.18%
1/566 • 3 years
|
|
Cardiac disorders
Acute myocardial infarction/Myocardial infarction
|
0.35%
2/566 • 3 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.18%
1/566 • 3 years
|
|
Cardiac disorders
Cardiac failure aggravated
|
0.18%
1/566 • 3 years
|
|
Cardiac disorders
Paroxysmal upraventricular tachycardia
|
0.18%
1/566 • 3 years
|
|
Cardiac disorders
Pericarditis
|
0.18%
1/566 • 3 years
|
|
Cardiac disorders
Tachycardia
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
3/566 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.35%
2/566 • 3 years
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Colitis ulcerative aggravated
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Epigastric pain
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Fistula
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Hypochondrium pain right
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Hypogastric pain
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Melaena
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Paresthesia circumoral
|
0.18%
1/566 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
1/566 • 3 years
|
|
General disorders
Fever/Pyrexia
|
1.2%
7/566 • 3 years
|
|
General disorders
Weakness/Asthenia
|
0.71%
4/566 • 3 years
|
|
General disorders
Fatigue
|
0.35%
2/566 • 3 years
|
|
General disorders
Difficulty in walking
|
0.18%
1/566 • 3 years
|
|
General disorders
Drug ineffective
|
0.18%
1/566 • 3 years
|
|
General disorders
Edema abdomen
|
0.18%
1/566 • 3 years
|
|
General disorders
Edema of legs
|
0.18%
1/566 • 3 years
|
|
General disorders
Nodule on finger
|
0.18%
1/566 • 3 years
|
|
General disorders
Pain
|
0.18%
1/566 • 3 years
|
|
General disorders
Reaction unevaluable
|
0.18%
1/566 • 3 years
|
|
General disorders
Swelling
|
0.18%
1/566 • 3 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.18%
1/566 • 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/566 • 3 years
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.18%
1/566 • 3 years
|
|
Immune system disorders
Anaphylaxis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Respiratory tract infection
|
0.53%
3/566 • 3 years
|
|
Infections and infestations
Viral infection
|
0.35%
2/566 • 3 years
|
|
Infections and infestations
Abscesses of skin
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Cellulitis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Cystitis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Herpes zoster
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Osteomyelitis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Periapical dental abscess
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Perirectal abscess
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Peritonitis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Peritonsillar abscess
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Phlegmon
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Pneumonia
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Post operative infection
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Postoperative wound infection
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Pyelonephritis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Relapsing fever
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Septic arthritis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Tuberculous peritonitis
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Viral hepatitis B
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
5/566 • 3 years
|
|
Injury, poisoning and procedural complications
Automobile Accident
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Bimalleolar fracture
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Elbow fracture
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.18%
1/566 • 3 years
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.18%
1/566 • 3 years
|
|
Investigations
Weight Loss/Weight decreased
|
0.35%
2/566 • 3 years
|
|
Investigations
Creatine increased
|
0.18%
1/566 • 3 years
|
|
Investigations
Erythrocyte sedimentation rate increased
|
0.18%
1/566 • 3 years
|
|
Investigations
Hematocrit decreased
|
0.18%
1/566 • 3 years
|
|
Investigations
Transaminases increased/Hepatic enzyme increased
|
0.18%
1/566 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
RA flare up
|
0.71%
4/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
0.35%
2/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis single joint
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Hydrarthrosis
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc herniation
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Periarticular disorder
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.18%
1/566 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Wrist deformity
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukemia
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Collecting duct renal cancer
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung nodule
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell cancer stage III
|
0.18%
1/566 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid adenoma
|
0.18%
1/566 • 3 years
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.35%
2/566 • 3 years
|
|
Nervous system disorders
Loss of consciousness
|
0.35%
2/566 • 3 years
|
|
Nervous system disorders
Demyelinating disease (excl. multiple sclerosis)
|
0.18%
1/566 • 3 years
|
|
Nervous system disorders
Movements reduced
|
0.18%
1/566 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.18%
1/566 • 3 years
|
|
Psychiatric disorders
Depression
|
0.18%
1/566 • 3 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.18%
1/566 • 3 years
|
|
Renal and urinary disorders
Renal colic
|
0.18%
1/566 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.35%
2/566 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.35%
2/566 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.18%
1/566 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.18%
1/566 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.18%
1/566 • 3 years
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.18%
1/566 • 3 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.18%
1/566 • 3 years
|
|
Surgical and medical procedures
Fusion lumbar spine
|
0.18%
1/566 • 3 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.18%
1/566 • 3 years
|
|
Surgical and medical procedures
Removal of surgical hardware
|
0.18%
1/566 • 3 years
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.18%
1/566 • 3 years
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/566 • 3 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.18%
1/566 • 3 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.18%
1/566 • 3 years
|
Other adverse events
| Measure |
Humira
n=566 participants at risk
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
|
|---|---|
|
General disorders
Drug ineffective
|
16.1%
91/566 • 3 years
|
|
Infections and infestations
Respiratory infection
|
6.2%
35/566 • 3 years
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
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