DALI: Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01078571
• Collaborator: (none)
• Enrollment: 705
• Locations: 40
• Duration (Months): 48
• Patients Per Site: 17.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions.The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: adalimumab (HUMIRA®)

Detailed Description

Main objective

• To evaluate safety and tolerability of adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.

Secondary objectives

• To evaluate the effectiveness of the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions in accordance with SER recommendations:

• To evaluate the life quality associated to the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.

• To describe the profile of patients who are in treatment with adalimumab (HUMIRA) biological therapy.

Study Design

• Study Type: Observational
• Actual Enrollment: 705 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
RA patients in treatment with adalimumab (Humira) RA patients in treatment with adalimumab (Humira) at 40mg alternate weeks	Biological: adalimumab (HUMIRA®); The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.; Other Names: HUMIRA® adalimumab

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment [Baseline, 1, 4, 6, and 12 months]

   The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.

Secondary Outcome Measures

1. Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). [Baseline and 12 months]

   The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented.

2. Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). [Baseline and 12 months]

   The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented.

3. Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. [Baseline, 1, 4, 6, and 12 months]

   The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.

4. Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. [Baseline and 12 months]

   Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).

5. Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. [Baseline and 12 Months]

   Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.

6. Radiological Evaluation of Rheumatoid Arthritis (RA). [Baseline and 12 months]

   Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients older than 18 years

• Patients who underwent adalimumab treatment at least for the previous 4 months before baseline visit, who have a good therapeutic response to treatment and have not been involved in previous clinical studies with Adalimumab or

• Patients who previously to the baseline visit, have been prescribe adalimumab complying treatment indication according to SER (Sociedad Española de Reumatología,

Spanish Society of Rheumatology) recommendations:

• Patients who had provided informed consent.

• Patients who have been prescribed adalimumab according to the Summary of Product Characteristics

Exclusion Criteria:

• Patients in whom a continued 12- months follow up is not anticipated.

• The contraindications specified in the Summary of Products Characteristics

• Hypersensibility to some of the components of the medication to administer.

• Any pathology shown by the patient that, according to medical criterion, contraindicates the treatment indicated in the protocol according to the Summary of Products Characteristics of adalimumab (HUMIRA®).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 29714	A Coruna		Spain	15006
2	Site Reference ID/Investigator# 29061	Algeciras		Spain	11207
3	Site Reference ID/Investigator# 29710	Almeria		Spain	04009
4	Site Reference ID/Investigator# 29719	Barcelona		Spain	08003
5	Site Reference ID/Investigator# 29054	Barcelona		Spain	08025
6	Site Reference ID/Investigator# 29698	Barcelona		Spain	08025
7	Site Reference ID/Investigator# 29063	Barcelona		Spain	08035
8	Site Reference ID/Investigator# 29718	Barcelona		Spain	08035
9	Site Reference ID/Investigator# 29720	Barcelona		Spain	08036
10	Site Reference ID/Investigator# 29706	Cadiz		Spain	11009
11	Site Reference ID/Investigator# 29052	Calella		Spain	08370
12	Site Reference ID/Investigator# 29065	Cartagena		Spain	30203
13	Site Reference ID/Investigator# 29713	Cordoba		Spain	14004
14	Site Reference ID/Investigator# 29703	El Palmar		Spain	31120
15	Site Reference ID/Investigator# 28607	Ferrol		Spain	15405
16	Site Reference ID/Investigator# 5338	Girona		Spain	17002
17	Site Reference ID/Investigator# 29701	Granada		Spain	18014
18	Site Reference ID/Investigator# 29711	Hospitalet de Llobregat		Spain	08907
19	Site Reference ID/Investigator# 29705	Huelva		Spain	21080
20	Site Reference ID/Investigator# 29050	Ibiza		Spain	07800
21	Site Reference ID/Investigator# 29708	Jaen		Spain	23007
22	Site Reference ID/Investigator# 29709	Jerez		Spain	11407
23	Site Reference ID/Investigator# 29716	Lugo		Spain	27004
24	Site Reference ID/Investigator# 29700	Malaga		Spain	29009
25	Site Reference ID/Investigator# 29038	Manacor		Spain	07500
26	Site Reference ID/Investigator# 29712	Mataro, Barcelona		Spain	08304
27	Site Reference ID/Investigator# 29051	Orense		Spain	32005
28	Site Reference ID/Investigator# 29699	Palma de Mallorca		Spain	07014
29	Site Reference ID/Investigator# 29717	Pamplona		Spain	31000
30	Site Reference ID/Investigator# 29704	Reus		Spain	43201
31	Site Reference ID/Investigator# 29715	Santiago de Compostela		Spain	15706
32	Site Reference ID/Investigator# 29068	Sevilla		Spain	41013
33	Site Reference ID/Investigator# 30823	Seville		Spain	41009
34	Site Reference ID/Investigator# 29064	Tarragona		Spain	43003
35	Site Reference ID/Investigator# 29058	Valls		Spain	43800
36	Site Reference ID/Investigator# 29055	Vic		Spain	08500
37	Site Reference ID/Investigator# 29702	Vigo/Pontevedra		Spain	36200
38	Site Reference ID/Investigator# 29697	Vigo		Spain	36204
39	Site Reference ID/Investigator# 29059	Vigo		Spain	36211
40	Site Reference ID/Investigator# 29053	Viladecans		Spain	08840

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Ana M Ruiz-Zorrilla, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01078571
• Other Study ID Numbers: P10-077
• First Posted: Mar 2, 2010
• Last Update Posted: Oct 28, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Abbott: Rheumatoid Arthritis; Biologic; Tumor Necrosis Factors blockers agents Monoclonal antibody
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab

Study Results

Participant Flow

Arm/Group Title	Adalimumab Treatment
Arm/Group Description	Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Period Title: Overall Study
STARTED	705
Safety Population	675
Intent-to-treat (ITT) Population	591
COMPLETED	590
NOT COMPLETED	115

Baseline Characteristics

Arm/Group Title	Adalimumab (Humira)
Arm/Group Description
Overall Participants	591
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.15 (12.43)
Sex/Gender, Customized (participants) [Number]
Female	461 78%
Male	127 21.5%
Gender not reported	3 0.5%
Region of Enrollment (participants) [Number]
Spain	591 100%
Time from Diagnosis of Rheumatoid Arthritis (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	8.56 (6.86)
Positivity of the Rheumatoid Factor (participants) [Number]
Positive for Rheumatoid Factor	460 77.8%
Negative for Rheumatoid Factor	114 19.3%
Rheumatoid Factor Results Unknown or Missing	17 2.9%
Previous Rheumatoid Arthritis Treatment (participants) [Number]
Had previous rheumatoid arthritis treatment	588 99.5%
No previous rheumatoid arthritis treatment	3 0.5%

Outcome Measures

1. Primary Outcome

Title	Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment
Description	The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.
Time Frame	Baseline, 1, 4, 6, and 12 months

Outcome Measure Data

Analysis Population Description

This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).

Arm/Group Title	Adalimumab Treatment
Arm/Group Description	Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
Measure Participants	675
Overall: Experienced a serious adverse event	28 4.7%
Overall: Experienced a non-serious AE	184 31.1%
Overall: Discontinued from study due to an AE	36 6.1%
Incidence: At least 1 AE at Baseline	53 9%
-- Incidence: At least 1 AE at 1 month	49 8.3%
-- Incidence: At least 1 AE at 4 months	50 8.5%
-- Incidence: At least 1 AE at 6 months	47 8%
-- Incidence: At least 1 AE at 12 months	51 8.6%
Incidence: At least 1 SAE at Baseline	4 0.7%
-- Incidence: At least 1 SAE at 1 month	4 0.7%
-- Incidence: At least 1 SAE at 4 months	6 1%
-- Incidence: At least 1 SAE at 6 months	6 1%
-- Incidence: At least 1 SAE at 12 months	8 1.4%

2. Secondary Outcome

Title	Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
Description	The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treated for Greater Than 4 Months)
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	310	281
Mean (Standard Deviation) [Units on a scale]	1.62 (1.61)	0.21 (1.23)

3. Secondary Outcome

Title	Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
Description	The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treated for Greater Than 4 Months)
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	310	279
Mean (Standard Deviation) [Percentage reduction]	0.28 (0.34)	0.01 (0.42)

4. Secondary Outcome

Title	Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.
Description	The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.
Time Frame	Baseline, 1, 4, 6, and 12 months

Outcome Measure Data

Analysis Population Description

This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treated for Greater Than 4 Months)
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	310	281
Painful Joints at Baseline (n=310 and n =281)	7.93 (6.31)	2.22 (3.39)
-- At 1 month (n=277 and n=203)	4.11 (5.13)	1.67 (3.07)
-- At 4 months (n=292 and n=271)	2.99 (4.14)	1.76 (2.99)
-- At 6 months (n=269 and n=267)	2.53 (3.42)	1.71 (2.86)
-- At 12 months (n=255 and n=262)	2.46 (3.33)	1.61 (3.03)
Swollen Joints at Baseline (n=310 and n=281)	6.19 (5.01)	1.39 (2.41)
-- At 1 month (n=277 and n= 204)	2.94 (3.89)	1.03 (2.16)
-- At 4 months (n=292 and n=272)	2.33 (3.39)	1.04 (2.10)
-- At 6 months (n=269 and n=266)	2.53 (3.42)	1.00 (2.02)
-- At 12 months (n=255 and n=262)	1.73 (2.83)	0.97 (2.00)

5. Secondary Outcome

Title	Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.
Description	Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treated for Greater Than 4 Months)
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	305	280
Mean (Standard Deviation) [Units on a scale]	0.44 (0.67)	0.05 (0.48)

6. Secondary Outcome

Title	Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.
Description	Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treatment for Greater Than 4 Months)
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	297	238
Mean (Standard Deviation) [Percentage change]	0.25 (0.79)	-0.09 (1.54)

7. Secondary Outcome

Title	Radiological Evaluation of Rheumatoid Arthritis (RA).
Description	Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

This analysis was conducted in the intent-to-treat population (591 participants total).

Arm/Group Title	Adalimumab (De Novo)	Adalimumab (Treated for Greater Than 4 Months
Arm/Group Description	Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as "de novo" participants.	Participants who had been taking adalimumab for 4 months or longer.
Measure Participants	310	281
Total number evaluated or not reported at Baseline	310	281
a) Radiological erosions present	153	156
b) Radiological erosions not present	75	57
c) Radiological erosions unknown	54	50
Total evaluated or not reported at 12 months	310	281
a) Radiological erosions present	58	97
b) Radiological erosions not present	49	45
c) Radiological erosions unknown	135	97

Adverse Events

Time Frame	All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of adalimumab.
Adverse Event Reporting Description	The safety population included all participants who received at least one dose of adalimumab (675 total). While 184 participants experienced a non-serious adverse event, 18 experienced non-serious adverse events that had an incidence greater than 1% and are presented in the Other Adverse Event table.
Arm/Group Title	Adalimumab Treatment
Arm/Group Description	Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
All Cause Mortality
	Adalimumab Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Adalimumab Treatment
	Affected / at Risk (%)	# Events
Total	28/675 (4.1%)
Cardiac disorders
Acute coronary syndrome	1/675 (0.1%)
Acute myocardial infarction	2/675 (0.3%)
Cardiac failure	1/675 (0.1%)
Pericarditis	1/675 (0.1%)
Gastrointestinal disorders
Pancreatitis acute	1/675 (0.1%)
General disorders
Pain	1/675 (0.1%)
Hepatobiliary disorders
Hypertransaminasaemia	1/675 (0.1%)
Infections and infestations
Abscess	1/675 (0.1%)
Arthritis bacterial	2/675 (0.3%)
Bacteraemia/listeriosis	1/675 (0.1%)
Diarrhoea/pyrexia/salmonellosis	1/675 (0.1%)
Herpes zoster	1/675 (0.1%)
Lower respiratory tract infection	1/675 (0.1%)
Respiratory tract infection	1/675 (0.1%)
Upper respiratory tract infection	1/675 (0.1%)
Injury, poisoning and procedural complications
Fracture	1/675 (0.1%)
Radius fracture/sternal fracture	1/675 (0.1%)
Musculoskeletal and connective tissue disorders
Lupus-like syndrome	1/675 (0.1%)
Sjogren's syndrome	1/675 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/675 (0.1%)
Malignant melanoma	1/675 (0.1%)
Ovarian cancer	1/675 (0.1%)
Nervous system disorders
Cerebrovascular accident	1/675 (0.1%)
Dizziness	1/675 (0.1%)
Psychiatric disorders
Anxiety	1/675 (0.1%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	1/675 (0.1%)
Pulmonary embolism	1/675 (0.1%)
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus	1/675 (0.1%)
Other (Not Including Serious) Adverse Events
	Adalimumab Treatment
	Affected / at Risk (%)	# Events
Total	18/675 (2.7%)
Infections and infestations
Respiratory tract infection	8/675 (1.2%)
Urinary tract infection	10/675 (1.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.