A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01086033
• Collaborator: (none)
• Enrollment: 566
• Locations: 60
• Duration (Months): 74
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis

Detailed Description

This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.

Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.

Study Design

• Study Type: Observational
• Actual Enrollment: 566 participants
• Time Perspective: Prospective
• Official Title: A 3-year Post-marketing Observational Study Following up Patients With Moderate to Severe RA Treated With Humira in Greece
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Humira Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [3 years]

   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.

2. Disease Activity Score (DAS) 28 Over Time [Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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.

3. European League Against Rheumatism (EULAR) Response [Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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.

4. Number of Participants With an American College of Rheumatology (ACR) 20 Response [Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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]).

5. Number of Participants With an American College of Rheumatology (ACR) 50 Response [Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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]).

6. Number of Participants With an American College of Rheumatology (ACR) 70 Response [Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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]).

Secondary Outcome Measures

1. Percentage of Participants Who Missed at Least One Dose of Humira [Months 3, 6, 9, 12, 18, 24, 30, and 36]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.

• Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

• Contraindications according to the SPC.

• Patients should not participate in another observational Abbott study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 30116	A. Glyfada		Greece
2	Site Reference ID/Investigator# 47544	Ag. Dimitrios, Athens		Greece	17121
3	Site Reference ID/Investigator# 47542	Ag. Paraskevi, Athens		Greece	15343
4	Site Reference ID/Investigator# 29992	Agioi Anargyroi		Greece	13122
5	Site Reference ID/Investigator# 29954	Agioi Anargyroi		Greece
6	Site Reference ID/Investigator# 29915	Alexandroupoli		Greece	68100
7	Site Reference ID/Investigator# 30118	Arta		Greece	47100
8	Site Reference ID/Investigator# 29989	Athens		Greece	10444
9	Site Reference ID/Investigator# 29914	Athens		Greece	115 21
10	Site Reference ID/Investigator# 29950	Athens		Greece	115 25
11	Site Reference ID/Investigator# 5284	Athens		Greece	115 25
12	Site Reference ID/Investigator# 29944	Athens		Greece	115 27
13	Site Reference ID/Investigator# 30474	Athens		Greece	115 27
14	Site Reference ID/Investigator# 29953	Athens		Greece	11521
15	Site Reference ID/Investigator# 30085	Athens		Greece	11521
16	Site Reference ID/Investigator# 30472	Athens		Greece	11521
17	Site Reference ID/Investigator# 30479	Athens		Greece	11527
18	Site Reference ID/Investigator# 30480	Athens		Greece	11527
19	Site Reference ID/Investigator# 29899	Athens		Greece	11528
20	Site Reference ID/Investigator# 30178	Athens		Greece	11635
21	Site Reference ID/Investigator# 30785	Athens		Greece	12462
22	Site Reference ID/Investigator# 30788	Athens		Greece	12462
23	Site Reference ID/Investigator# 30198	Chalkida		Greece	34100
24	Site Reference ID/Investigator# 30008	Crete		Greece	71201
25	Site Reference ID/Investigator# 30210	Crete		Greece	74100
26	Site Reference ID/Investigator# 29828	Crete		Greece
27	Site Reference ID/Investigator# 30105	Drama		Greece	66100
28	Site Reference ID/Investigator# 29820	Elefsina		Greece	19200
29	Site Reference ID/Investigator# 30146	Ermoupolis Syros		Greece
30	Site Reference ID/Investigator# 30767	Heraklion Crete		Greece	70013
31	Site Reference ID/Investigator# 30789	Holargos		Greece	15562
32	Site Reference ID/Investigator# 30482	Ioannina		Greece	45500
33	Site Reference ID/Investigator# 47322	Karditsa		Greece	43100
34	Site Reference ID/Investigator# 29850	Katerini		Greece
35	Site Reference ID/Investigator# 30189	Kavala		Greece	65302
36	Site Reference ID/Investigator# 30476	Kifisia		Greece	14500
37	Site Reference ID/Investigator# 30004	Kozani		Greece	50100
38	Site Reference ID/Investigator# 29993	Lamia		Greece	35100
39	Site Reference ID/Investigator# 29988	Larisa		Greece	41223
40	Site Reference ID/Investigator# 30770	Larissa		Greece	411 10
41	Site Reference ID/Investigator# 29922	Nikea		Greece	18454
42	Site Reference ID/Investigator# 29972	Patras		Greece	26221
43	Site Reference ID/Investigator# 29916	Patras		Greece	26335
44	Site Reference ID/Investigator# 29827	Peristeri		Greece	12134
45	Site Reference ID/Investigator# 29936	Pyrgos		Greece
46	Site Reference ID/Investigator# 30200	Rion, Patras		Greece	265 00
47	Site Reference ID/Investigator# 29900	Thessaloniki		Greece	54622
48	Site Reference ID/Investigator# 30192	Thessaloniki		Greece	54622
49	Site Reference ID/Investigator# 30165	Thessaloniki		Greece	54623
50	Site Reference ID/Investigator# 30765	Thessaloniki		Greece	54636
51	Site Reference ID/Investigator# 29845	Thessaloniki		Greece	54639
52	Site Reference ID/Investigator# 30791	Thessaloniki		Greece	54642
53	Site Reference ID/Investigator# 30792	Thessaloniki		Greece	54642
54	Site Reference ID/Investigator# 47543	Thessaloniki		Greece	54643
55	Site Reference ID/Investigator# 29924	Thessaloniki		Greece	55134
56	Site Reference ID/Investigator# 30477	Thessaloniki		Greece	564 29
57	Site Reference ID/Investigator# 29947	Thessaloniki		Greece	570 10
58	Site Reference ID/Investigator# 30115	Trikala		Greece	42100
59	Site Reference ID/Investigator# 30084	Veria		Greece
60	Site Reference ID/Investigator# 29968	Xanthi		Greece	67100

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Chair: Thanasis Floros, MD, AbbVie Pharmaceuticals S.A.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01086033
• Other Study ID Numbers: PMOS GREC 2004 06
• First Posted: Mar 12, 2010
• Last Update Posted: Sep 26, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by AbbVie (prior sponsor, Abbott): Evaluation of safety and efficacy; Adalimumab treatment; Rheumatoid Arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Period Title: Overall Study
STARTED	566
COMPLETED	262
NOT COMPLETED	304

Baseline Characteristics

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Overall Participants	566
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (13.2)
Sex: Female, Male (Count of Participants)
Female	456 80.6%
Male	110 19.4%
Region of Enrollment (participants) [Number]
Greece	566 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	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.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The safety population, including all patients that received at least one dose of the study drug.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Any Adverse Event	262 46.3%
Serious Adverse Event	65 11.5%

2. Primary Outcome

Title	Disease Activity Score (DAS) 28 Over Time
Description	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.
Time Frame	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Safety population; "n" indicates the number of participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Baseline (n=555)	6.0 (1.2)
Month 3 (n=510)	4.2 (1.4)
Month 6 (n=449)	3.8 (1.5)
Month 9 (n=401)	3.5 (1.5)
Month 12 (n=379)	3.5 (1.5)
Month 18 (n=333)	3.3 (1.5)
Month 24 (n=298)	3.2 (1.5)
Month 30 (n=264)	3.0 (1.4)
Month 36 (n=254)	2.9 (1.4)

3. Primary Outcome

Title	European League Against Rheumatism (EULAR) Response
Description	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.
Time Frame	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Safety population;

Arm/Group Title	Good Response	Moderate Response	No Response
Arm/Group Description	Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.	Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.	Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
Measure Participants	566	566	566
Month 3 (n=501)	112 19.8%	242 NaN	147 NaN
Month 6 (n=443)	154 27.2%	193 NaN	96 NaN
Month 9 (n=394)	173 30.6%	147 NaN	74 NaN
Month 12 (n=373)	171 30.2%	139 NaN	63 NaN
Month 18 (n=327)	168 29.7%	105 NaN	54 NaN
Month 24 (n=294)	169 29.9%	84 NaN	41 NaN
Month 30 (n=262)	155 27.4%	78 NaN	29 NaN
Month 36 (n=253)	156 27.6%	68 NaN	29 NaN

4. Primary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 20 Response
Description	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]).
Time Frame	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Month 3 (n=491)	265 46.8%
Month 6 (n=427)	279 49.3%
Month 9 (n=384)	263 46.5%
Month 12 (n=363)	248 43.8%
Month 18 (n=330)	241 42.6%
Month 24 (n=293)	216 38.2%
Month 30 (n=259)	198 35%
Month 36 (n=248)	194 34.3%

5. Primary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 50 Response
Description	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]).
Time Frame	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Month 3 (n=498)	134 23.7%
Month 6 (n=433)	188 33.2%
Month 9 (n=388)	205 36.2%
Month 12 (n=368)	182 32.2%
Month 18 (n=333)	184 32.5%
Month 24 (n=291)	170 30%
Month 30 (n=256)	161 28.4%
Month 36 (n=250)	164 29%

6. Primary Outcome

Title	Number of Participants With an American College of Rheumatology (ACR) 70 Response
Description	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]).
Time Frame	Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Month 3 (n=495)	67 11.8%
Month 6 (n=435)	118 20.8%
Month 9 (n=390)	147 26%
Month 12 (n=373)	142 25.1%
Month 18 (n=330)	154 27.2%
Month 24 (n=294)	149 26.3%
Month 30 (n=261)	139 24.6%
Month 36 (n=253)	144 25.4%

7. Secondary Outcome

Title	Percentage of Participants Who Missed at Least One Dose of Humira
Description	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.
Time Frame	Months 3, 6, 9, 12, 18, 24, 30, and 36

Outcome Measure Data

Analysis Population Description

Safety population; "n" indicates the number of participants with available data at each time point.

Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Measure Participants	566
Month 3 (n=512)	6.6 1.2%
Month 6 (n=451)	8.6 1.5%
Month 9 (n=406)	7.4 1.3%
Month 12 (n=384)	7.3 1.3%
Month 18 (n=341)	8.2 1.4%
Month 24 (n=303)	7.6 1.3%
Month 30 (n=271)	5.5 1%
Month 36 (n=262)	4.2 0.7%

Adverse Events

Time Frame	3 years
Arm/Group Title	Humira
Arm/Group Description	Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
All Cause Mortality
	Humira
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Humira
	Affected / at Risk (%)	# Events
Total	65/566 (11.5%)
Blood and lymphatic system disorders
Anemia	2/566 (0.4%)
Lymph nodes enlarged	1/566 (0.2%)
Pancytopenia	1/566 (0.2%)
Thrombocytopenia	1/566 (0.2%)
Thrombotic thrombocytopenic purpura	1/566 (0.2%)
Cardiac disorders
Acute myocardial infarction/Myocardial infarction	2/566 (0.4%)
Atrioventricular block complete	1/566 (0.2%)
Cardiac failure aggravated	1/566 (0.2%)
Paroxysmal upraventricular tachycardia	1/566 (0.2%)
Pericarditis	1/566 (0.2%)
Tachycardia	1/566 (0.2%)
Gastrointestinal disorders
Abdominal pain	3/566 (0.5%)
Diarrhea	2/566 (0.4%)
Abdominal bloating	1/566 (0.2%)
Ascites	1/566 (0.2%)
Colitis ulcerative aggravated	1/566 (0.2%)
Dysphagia	1/566 (0.2%)
Epigastric pain	1/566 (0.2%)
Fistula	1/566 (0.2%)
Gastrointestinal bleeding	1/566 (0.2%)
Hypochondrium pain right	1/566 (0.2%)
Hypogastric pain	1/566 (0.2%)
Melaena	1/566 (0.2%)
Nausea	1/566 (0.2%)
Pancreatic disorder	1/566 (0.2%)
Paresthesia circumoral	1/566 (0.2%)
Vomiting	1/566 (0.2%)
General disorders
Fever/Pyrexia	7/566 (1.2%)
Weakness/Asthenia	4/566 (0.7%)
Fatigue	2/566 (0.4%)
Difficulty in walking	1/566 (0.2%)
Drug ineffective	1/566 (0.2%)
Edema abdomen	1/566 (0.2%)
Edema of legs	1/566 (0.2%)
Nodule on finger	1/566 (0.2%)
Pain	1/566 (0.2%)
Reaction unevaluable	1/566 (0.2%)
Swelling	1/566 (0.2%)
Hepatobiliary disorders
Cholangitis	1/566 (0.2%)
Cholecystitis	1/566 (0.2%)
Gallbladder perforation	1/566 (0.2%)
Immune system disorders
Anaphylaxis	1/566 (0.2%)
Infections and infestations
Respiratory tract infection	3/566 (0.5%)
Viral infection	2/566 (0.4%)
Abscesses of skin	1/566 (0.2%)
Cellulitis	1/566 (0.2%)
Cystitis	1/566 (0.2%)
Escherichia urinary tract infection	1/566 (0.2%)
Herpes zoster	1/566 (0.2%)
Osteomyelitis	1/566 (0.2%)
Periapical dental abscess	1/566 (0.2%)
Perirectal abscess	1/566 (0.2%)
Peritonitis	1/566 (0.2%)
Peritonsillar abscess	1/566 (0.2%)
Phlegmon	1/566 (0.2%)
Pneumonia	1/566 (0.2%)
Post operative infection	1/566 (0.2%)
Postoperative wound infection	1/566 (0.2%)
Pyelonephritis	1/566 (0.2%)
Relapsing fever	1/566 (0.2%)
Septic arthritis	1/566 (0.2%)
Tuberculous peritonitis	1/566 (0.2%)
Urinary tract infection	1/566 (0.2%)
Viral hepatitis B	1/566 (0.2%)
Lower respiratory tract infection	1/566 (0.2%)
Injury, poisoning and procedural complications
Fall	5/566 (0.9%)
Automobile Accident	1/566 (0.2%)
Bimalleolar fracture	1/566 (0.2%)
Elbow fracture	1/566 (0.2%)
Femoral neck fracture	1/566 (0.2%)
Femur fracture	1/566 (0.2%)
Hip fracture	1/566 (0.2%)
Postoperative hernia	1/566 (0.2%)
Shoulder fracture	1/566 (0.2%)
Investigations
Weight Loss/Weight decreased	2/566 (0.4%)
Creatine increased	1/566 (0.2%)
Erythrocyte sedimentation rate increased	1/566 (0.2%)
Hematocrit decreased	1/566 (0.2%)
Transaminases increased/Hepatic enzyme increased	1/566 (0.2%)
Metabolism and nutrition disorders
Hypoglycemia	1/566 (0.2%)
Musculoskeletal and connective tissue disorders
RA flare up	4/566 (0.7%)
Pain in hip	2/566 (0.4%)
Arthralgia	1/566 (0.2%)
Arthritis	1/566 (0.2%)
Arthritis single joint	1/566 (0.2%)
Back pain	1/566 (0.2%)
Hydrarthrosis	1/566 (0.2%)
Intervertebral disc herniation	1/566 (0.2%)
Lumbar disc herniation	1/566 (0.2%)
Lupus-like syndrome	1/566 (0.2%)
Muscle weakness	1/566 (0.2%)
Periarticular disorder	1/566 (0.2%)
Polyarthritis	1/566 (0.2%)
Synovial cyst	1/566 (0.2%)
Wrist deformity	1/566 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukemia	1/566 (0.2%)
Collecting duct renal cancer	1/566 (0.2%)
Lung Cancer	1/566 (0.2%)
Lung nodule	1/566 (0.2%)
Non-small cell lung cancer	1/566 (0.2%)
Ovarian cancer	1/566 (0.2%)
Ovarian germ cell cancer stage III	1/566 (0.2%)
Parathyroid adenoma	1/566 (0.2%)
Nervous system disorders
Hemorrhagic stroke	2/566 (0.4%)
Loss of consciousness	2/566 (0.4%)
Demyelinating disease (excl. multiple sclerosis)	1/566 (0.2%)
Movements reduced	1/566 (0.2%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/566 (0.2%)
Psychiatric disorders
Depression	1/566 (0.2%)
Renal and urinary disorders
Nephrotic syndrome	1/566 (0.2%)
Renal colic	1/566 (0.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/566 (0.4%)
Pulmonary fibrosis	2/566 (0.4%)
Productive cough	1/566 (0.2%)
Throat pain	1/566 (0.2%)
Skin and subcutaneous tissue disorders
Hair loss	1/566 (0.2%)
Maculopapular rash	1/566 (0.2%)
Surgical and medical procedures
Cholecystectomy	1/566 (0.2%)
Fusion lumbar spine	1/566 (0.2%)
Knee arthroplasty	1/566 (0.2%)
Removal of surgical hardware	1/566 (0.2%)
Vascular disorders
Abdominal aortic aneurysm	1/566 (0.2%)
Hypertensive crisis	1/566 (0.2%)
Venous thrombosis limb	1/566 (0.2%)
Other (Not Including Serious) Adverse Events
	Humira
	Affected / at Risk (%)	# Events
Total	109/566 (19.3%)
General disorders
Drug ineffective	91/566 (16.1%)
Infections and infestations
Respiratory infection	35/566 (6.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.