Long Term Open Label Continuation Study

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00195650
• Collaborator: (none)
• Enrollment: 846
• Locations: 92
• Arm: 1
• Duration (Months): 130
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: Adalimumab	Phase 3

Detailed Description

Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. Participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). Participants who maintained an American College of Rheumatology 50% (ACR50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. Safety and efficacy data were collected over 520 weeks (10 years). Both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study DE020 (the Full Analysis Set, n=846). Three patients who entered the continuation study but were never dosed were excluded from all analyses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 846 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis
• Study Start Date: Jul 1, 2000
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adalimumab Open-label adalimumab 40 mg	Biological: Adalimumab; Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years); Other Names: Humira, ABT-D2E7

Outcome Measures

Primary Outcome Measures

1. Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 [Week 520]

   ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

2. Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 [Week 260]

   ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

3. Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 [Week 520]

   ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

4. Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 [Week 260]

   ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

5. Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 [Week 520]

   ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

6. Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 [Week 260]

   ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

7. Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520 [Week 520]

   Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

8. Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260 [Week 260]

   Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

9. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520 [Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520]

   The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

10. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260 [Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260]

    The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

Secondary Outcome Measures

1. Reported Adverse Events [Duration of study (up to 520 weeks [10 years])]

   Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.

Eligibility Criteria

Criteria

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

Inclusion Criteria

• Participant was in a prior D2E7 (adalimumab) study

• Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.

Exclusion Criteria

• Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study

• Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant

• Participant had any ongoing chronic or active infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 538	Birmingham	Alabama	United States	35205
2	Site Reference ID/Investigator# 4111	Birmingham	Alabama	United States	35294-7201
3	Site Reference ID/Investigator# 4113	Mobile	Alabama	United States	36608
4	Site Reference ID/Investigator# 408	Anchorage	Alaska	United States	99508
5	Site Reference ID/Investigator# 537	Tucson	Arizona	United States	85710
6	Site Reference ID/Investigator# 66822	Anaheim	California	United States	92801
7	Site Reference ID/Investigator# 557	La Jolla	California	United States	92037-0943
8	Site Reference ID/Investigator# 387	Los Angeles	California	United States	90048
9	Site Reference ID/Investigator# 555	Los Angeles	California	United States	90095
10	Site Reference ID/Investigator# 552	Santa Barbara	California	United States	93105
11	Site Reference ID/Investigator# 66864	Santa Monica	California	United States	90404
12	Site Reference ID/Investigator# 535	Stanford	California	United States	94305
13	Site Reference ID/Investigator# 3412	Upland	California	United States	91786
14	Site Reference ID/Investigator# 451	Westlake Village	California	United States	91361
15	Site Reference ID/Investigator# 572	Colorado Springs	Colorado	United States	80910
16	Site Reference ID/Investigator# 4109	Denver	Colorado	United States	80230
17	Site Reference ID/Investigator# 541	Danbury	Connecticut	United States	06810
18	Site Reference ID/Investigator# 654	Milford	Connecticut	United States	06460
19	Site Reference ID/Investigator# 655	Wilmington	Delaware	United States	19808
20	Site Reference ID/Investigator# 455	Daytona Beach	Florida	United States	32114
21	Site Reference ID/Investigator# 431	Fort Lauderdale	Florida	United States	33334
22	Site Reference ID/Investigator# 574	Fort Myers	Florida	United States	33901
23	Site Reference ID/Investigator# 66843	Gainesville	Florida	United States	32605
24	Site Reference ID/Investigator# 579	Orlando	Florida	United States	32804
25	Site Reference ID/Investigator# 571	Palm Harbor	Florida	United States	34684
26	Site Reference ID/Investigator# 651	Sarasota	Florida	United States	34239
27	Site Reference ID/Investigator# 66863	St. Petersburg	Florida	United States	33710
28	Site Reference ID/Investigator# 542	Tampa	Florida	United States	33609
29	Site Reference ID/Investigator# 415	Vero Beach	Florida	United States	32962
30	Site Reference ID/Investigator# 652	Zephyrhills	Florida	United States	33542
31	Site Reference ID/Investigator# 449	Boise	Idaho	United States	83702
32	Site Reference ID/Investigator# 4110	Boise	Idaho	United States	83706
33	Site Reference ID/Investigator# 650	Coeur D'Alene	Idaho	United States	83814
34	Site Reference ID/Investigator# 578	Chicago	Illinois	United States	60612
35	Site Reference ID/Investigator# 4112	Indianapolis	Indiana	United States	46260
36	Site Reference ID/Investigator# 547	Louisville	Kentucky	United States	40291
37	Site Reference ID/Investigator# 534	Metairie	Louisiana	United States	70006
38	Site Reference ID/Investigator# 544	Chevy Chase	Maryland	United States	20815
39	Site Reference ID/Investigator# 653	Boston	Massachusetts	United States	02115
40	Site Reference ID/Investigator# 4114	Worcester	Massachusetts	United States	01610
41	Site Reference ID/Investigator# 546	Petoskey	Michigan	United States	49770
42	Site Reference ID/Investigator# 577	St. Louis	Missouri	United States	63128
43	Site Reference ID/Investigator# 549	Billings	Montana	United States	59101
44	Site Reference ID/Investigator# 561	Reno	Nevada	United States	89502
45	Site Reference ID/Investigator# 573	Dover	New Jersey	United States	07801
46	Site Reference ID/Investigator# 66842	Toms River	New Jersey	United States	08755
47	Site Reference ID/Investigator# 559	Voorhees	New Jersey	United States	08043
48	Site Reference ID/Investigator# 562	Albuquerque	New Mexico	United States	87102
49	Site Reference ID/Investigator# 66823	Brooklyn	New York	United States	11203
50	Site Reference ID/Investigator# 432	Lake Success	New York	United States	11042
51	Site Reference ID/Investigator# 657	New York	New York	United States	10003
52	Site Reference ID/Investigator# 647	New York	New York	United States	10021
53	Site Reference ID/Investigator# 545	Port Jefferson Station	New York	United States	11776
54	Site Reference ID/Investigator# 540	Syracuse	New York	United States	13210
55	Site Reference ID/Investigator# 646	Statesville	North Carolina	United States	28625
56	Site Reference ID/Investigator# 438	Cincinnati	Ohio	United States	45219
57	Site Reference ID/Investigator# 436	Dayton	Ohio	United States	45408
58	Site Reference ID/Investigator# 548	Bend	Oregon	United States	97701
59	Site Reference ID/Investigator# 553	Eugene	Oregon	United States	97401
60	Site Reference ID/Investigator# 532	Portland	Oregon	United States	97205
61	Site Reference ID/Investigator# 570	Bethlehem	Pennsylvania	United States	18015
62	Site Reference ID/Investigator# 575	Ridley Park	Pennsylvania	United States	19078-2210
63	Site Reference ID/Investigator# 585	Willow Grove	Pennsylvania	United States	19090
64	Site Reference ID/Investigator# 2435	Dallas	Texas	United States	75231
65	Site Reference ID/Investigator# 536	Richmond	Virginia	United States	23219
66	Site Reference ID/Investigator# 649	Everett	Washington	United States	98201
67	Site Reference ID/Investigator# 66862	Everett	Washington	United States	98201
68	Site Reference ID/Investigator# 531	Kirkland	Washington	United States	98034
69	Site Reference ID/Investigator# 412	Olympia	Washington	United States	98502
70	Site Reference ID/Investigator# 658	Spokane	Washington	United States	99204
71	Site Reference ID/Investigator# 576	Vancouver	Washington	United States	98664
72	Site Reference ID/Investigator# 551	Yakima	Washington	United States	98902
73	Site Reference ID/Investigator# 656	Glendale	Wisconsin	United States	53217
74	Site Reference ID/Investigator# 539	Milwaukee	Wisconsin	United States	53215
75	Site Reference ID/Investigator# 513	Calgary		Canada	T2V 1P9
76	Site Reference ID/Investigator# 568	Charlottetown		Canada	C1A 5Y8
77	Site Reference ID/Investigator# 565	Hamilton		Canada	L8N 1Y2
78	Site Reference ID/Investigator# 564	Hamilton		Canada	L8N 2B6
79	Site Reference ID/Investigator# 569	Kitchener		Canada	N2M 5N6
80	Site Reference ID/Investigator# 3440	Montreal		Canada	H2L 1S6
81	Site Reference ID/Investigator# 413	Montreal		Canada	H3Z 2Z3
82	Site Reference ID/Investigator# 66805	North York		Canada	M3H 5Y8
83	Site Reference ID/Investigator# 66807	North York		Canada	M3H 5Y8
84	Site Reference ID/Investigator# 414	Ottawa		Canada	K1H 7W9
85	Site Reference ID/Investigator# 566	Pointe-Claire		Canada	H9J 3W3
86	Site Reference ID/Investigator# 2467	Sainte-Foy, Quebec		Canada	G1W 4R4
87	Site Reference ID/Investigator# 66804	Scarborough		Canada	M1B 4Y9
88	Site Reference ID/Investigator# 563	St. John's		Canada	A1B 3E1
89	Site Reference ID/Investigator# 2466	Toronto		Canada	M4N 3M5
90	Site Reference ID/Investigator# 567	Toronto		Canada	M5L 3L9
91	Site Reference ID/Investigator# 3442	Vancouver		Canada	V5Z 1L7
92	Site Reference ID/Investigator# 514	Winnipeg		Canada	R3A 1M4

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Hartmut Kupper, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT00195650
• Other Study ID Numbers: DE020
• First Posted: Sep 20, 2005
• Last Update Posted: Aug 31, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Abbott: Rheumatoid Arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab

Study Results

Participant Flow

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Period Title: Overall Study
STARTED	846
COMPLETED	321
NOT COMPLETED	525

Baseline Characteristics

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Overall Participants	846
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.6 (12.19)
Sex: Female, Male (Count of Participants)
Female	661 78.1%
Male	185 21.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520
Description	ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 520

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	238
Number [participants]	187 22.1%

2. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260
Description	ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 260

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	516
Number [participants]	402 47.5%

3. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520
Description	ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 520

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	238
Number [participants]	132 15.6%

4. Secondary Outcome

Title	Reported Adverse Events
Description	Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.
Time Frame	Duration of study (up to 520 weeks [10 years])

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	846
Number [participants]	808 95.5%

5. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260
Description	ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 260

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	516
Number [participants]	279 33%

6. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520
Description	ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 520

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	238
Number [participants]	78 9.2%

7. Primary Outcome

Title	Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260
Description	ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Time Frame	Week 260

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	516
Number [participants]	179 21.2%

8. Primary Outcome

Title	Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520
Description	Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).
Time Frame	Week 520

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	236
Number [participants]	135 16%

9. Primary Outcome

Title	Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260
Description	Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).
Time Frame	Week 260

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	513
Number [participants]	243 28.7%

10. Primary Outcome

Title	Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520
Description	The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.
Time Frame	Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	238
Mean (Standard Deviation) [units on a scale]	-0.52 (0.662)

11. Primary Outcome

Title	Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260
Description	The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.
Time Frame	Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).

Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
Measure Participants	515
Mean (Standard Deviation) [units on a scale]	-0.59 (0.628)

Adverse Events

Time Frame	After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Arm/Group Title	Adalimumab
Arm/Group Description	Open-label adalimumab 40 mg
All Cause Mortality
	Adalimumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Adalimumab
	Affected / at Risk (%)	# Events
Total	432/846 (51.1%)
Blood and lymphatic system disorders
Anaemia	8/846 (0.9%)
Disseminated intravascular coagulation	1/846 (0.1%)
Haemorrhagic anaemia	1/846 (0.1%)
Iron deficiency aenemia	1/846 (0.1%)
Pancytopenia	1/846 (0.1%)
Thrombocytopenia	1/846 (0.1%)
Cardiac disorders
Acute myocardial infarction	8/846 (0.9%)
Angina pectoris	14/846 (1.7%)
Angina unstable	3/846 (0.4%)
Arrhythmia	1/846 (0.1%)
Arteriosclerosis coronary artery	1/846 (0.1%)
Atrial fibrillation	9/846 (1.1%)
Atrial flutter	1/846 (0.1%)
Atrioventricular block complete	2/846 (0.2%)
Bradycardia	3/846 (0.4%)
Cardiac arrest	2/846 (0.2%)
Cardiac failure congestive	7/846 (0.8%)
Cardiac tamponade	1/846 (0.1%)
Cardio-respiratory arrest	1/846 (0.1%)
Coronary artery disease	10/846 (1.2%)
Coronary artery occlusion	1/846 (0.1%)
Myocardial infarction	10/846 (1.2%)
Myocardial ischaemia	2/846 (0.2%)
Pericardial disease	1/846 (0.1%)
Pericardial effusion	1/846 (0.1%)
Pericarditis	1/846 (0.1%)
Pericarditis adhesive	1/846 (0.1%)
Sick sinus syndrome	1/846 (0.1%)
Supraventricular tachycardia	3/846 (0.4%)
Tachycardia	1/846 (0.1%)
Ventricular tachycardia	1/846 (0.1%)
Congenital, familial and genetic disorders
Atrial septal defect	1/846 (0.1%)
Gastrointestinal angiodysplasia	1/846 (0.1%)
Gastrointestinal angiodysplasia haemorrhagic	1/846 (0.1%)
Heart disease congenital	1/846 (0.1%)
Ear and labyrinth disorders
Vertigo	1/846 (0.1%)
Vertigo positional	2/846 (0.2%)
Endocrine disorders
Adrenal insufficiency	1/846 (0.1%)
Goitre	4/846 (0.5%)
Hypothyroidism	1/846 (0.1%)
Eye disorders
Diplopia	1/846 (0.1%)
Maculopathy	1/846 (0.1%)
Vitreous haemorrhage	1/846 (0.1%)
Gastrointestinal disorders
Abdominal hernia	1/846 (0.1%)
Abdominal pain	2/846 (0.2%)
Abdominal pain lower	1/846 (0.1%)
Acute abdomen	1/846 (0.1%)
Ascites	1/846 (0.1%)
Colitis	1/846 (0.1%)
Colitis ischaemic	1/846 (0.1%)
Colonic polyp	1/846 (0.1%)
Constipation	1/846 (0.1%)
Diarrhoea	2/846 (0.2%)
Diverticular perforation	2/846 (0.2%)
Enterovesical fistula	1/846 (0.1%)
Faecaloma	1/846 (0.1%)
Gastric ulcer	2/846 (0.2%)
Gastritis	2/846 (0.2%)
Gastrointestinal haemorrhage	3/846 (0.4%)
Gastrointestinal perforation	1/846 (0.1%)
Gastrooesophageal reflux disease	1/846 (0.1%)
Haematochezia	1/846 (0.1%)
Haemorrhoidal haemorrhage	1/846 (0.1%)
Hiatus hernia, obstructive	2/846 (0.2%)
Ileus	1/846 (0.1%)
Impaired gastric emptying	1/846 (0.1%)
Inguinal hernia	2/846 (0.2%)
Intestinal infarction	1/846 (0.1%)
Intestinal perforation	1/846 (0.1%)
Irritable bowel syndrome	1/846 (0.1%)
Jejunal perforation	1/846 (0.1%)
Lower gastrointestinal haemorrhage	2/846 (0.2%)
Nausea	1/846 (0.1%)
Obstruction gastric	1/846 (0.1%)
Oesophageal perforation	1/846 (0.1%)
Oesophageal ulcer	1/846 (0.1%)
Oesophageal ulcer haemorrhage	1/846 (0.1%)
Pancreatic pseudocyst	1/846 (0.1%)
Pancreatitis	5/846 (0.6%)
Pancreatitis acute	1/846 (0.1%)
Peptic ulcer	1/846 (0.1%)
Peptic ulcer haemorrhage	1/846 (0.1%)
Peritonitis	1/846 (0.1%)
Rectal prolapse	1/846 (0.1%)
Small intestinal obstruction	1/846 (0.1%)
Upper gastrointestinal haemorrhage	2/846 (0.2%)
Volvulus	1/846 (0.1%)
Vomiting	2/846 (0.2%)
General disorders
Asthenia	1/846 (0.1%)
Chest discomfort	2/846 (0.2%)
Chest pain	1/846 (0.1%)
Death	1/846 (0.1%)
Device dislocation	5/846 (0.6%)
Device failure	2/846 (0.2%)
Gait disturbance	1/846 (0.1%)
Granuloma	1/846 (0.1%)
Medical device complication	1/846 (0.1%)
Multi-organ failure	2/846 (0.2%)
Non-cardiac chest pain	5/846 (0.6%)
Sudden death	1/846 (0.1%)
Xerosis	1/846 (0.1%)
Hepatobiliary disorders
Cholecystitis	5/846 (0.6%)
Cholecystitis acute	4/846 (0.5%)
Cholelithiasis	6/846 (0.7%)
Hepatic ischaemia	1/846 (0.1%)
Immune system disorders
Anaphylactic reaction	2/846 (0.2%)
Antiphospholipid syndrome	1/846 (0.1%)
Hypersensitivity	2/846 (0.2%)
Sarcoidosis	1/846 (0.1%)
Infections and infestations
Abscess limb	1/846 (0.1%)
Abscess rupture	1/846 (0.1%)
Appendiceal abscess	1/846 (0.1%)
Appendicitis	2/846 (0.2%)
Arthritis bacterial	4/846 (0.5%)
Arthritis infective	3/846 (0.4%)
Atypical mycobacterial infection	1/846 (0.1%)
Bacteraemia	2/846 (0.2%)
Bronchitis	1/846 (0.1%)
Bronchitis viral	2/846 (0.2%)
Bronchopneumonia	1/846 (0.1%)
Bursitis infective	1/846 (0.1%)
Cellulitis	20/846 (2.4%)
Cellulitis orbital	1/846 (0.1%)
Cellulitis staphylococcal	1/846 (0.1%)
Coccidioidomycosis	1/846 (0.1%)
Diverticulitis	4/846 (0.5%)
Endocarditis	1/846 (0.1%)
Escherichia urinary tract infection	1/846 (0.1%)
Gallbladder abscess	1/846 (0.1%)
Gangrene	1/846 (0.1%)
Gastroenteritis	5/846 (0.6%)
Gastroenteritis salmonella	1/846 (0.1%)
Gastroenteritis viral	2/846 (0.2%)
Gastrointestinal infection	1/846 (0.1%)
Herpes zoster opthalmic	1/846 (0.1%)
Influenza	1/846 (0.1%)
Labyrinthitis	1/846 (0.1%)
Lobar pneumonia	4/846 (0.5%)
Localised infection	3/846 (0.4%)
Lung abscess	1/846 (0.1%)
Lyme disease	1/846 (0.1%)
Meningitis viral	1/846 (0.1%)
Mycobacterium avium complex infection	1/846 (0.1%)
Necrotising fasciitis	2/846 (0.2%)
Nocardiosis	1/846 (0.1%)
Osteomyelitis	2/846 (0.2%)
Pelvic inflammatory disease	1/846 (0.1%)
Peritoneal tuberculosis	2/846 (0.2%)
Peritonsillar abscess	1/846 (0.1%)
Pneumonia	36/846 (4.3%)
Pneumonia bacterial	1/846 (0.1%)
Pneumonia legionella	1/846 (0.1%)
Post procedural infection	2/846 (0.2%)
Postoperative wound infection	1/846 (0.1%)
Sepsis	7/846 (0.8%)
Septic shock	1/846 (0.1%)
Sinusitis	1/846 (0.1%)
Staphylococcal abscess	1/846 (0.1%)
Staphylococcal bacteraemia	1/846 (0.1%)
Staphylococcal infection	3/846 (0.4%)
Staphylococcal sepsis	2/846 (0.2%)
Tracheobronchitis	1/846 (0.1%)
Urinary tract infection	5/846 (0.6%)
Urosepsis	7/846 (0.8%)
Viral infection	1/846 (0.1%)
West nile viral infection	1/846 (0.1%)
Wound infection	1/846 (0.1%)
Wound infection staphylococcal	1/846 (0.1%)
Injury, poisoning and procedural complications
Anaemia postoperative	2/846 (0.2%)
Ankle fracture	1/846 (0.1%)
Brain contusion	1/846 (0.1%)
Clavicle fracture	1/846 (0.1%)
Contusion	1/846 (0.1%)
Fall	1/846 (0.1%)
Femur fracture	5/846 (0.6%)
Fractured sacrum	1/846 (0.1%)
Gastrointestinal stoma complication	1/846 (0.1%)
Hip fracture	8/846 (0.9%)
Humerus fracture	4/846 (0.5%)
Joint dislocation	5/846 (0.6%)
Lumbar vertebral fracture	1/846 (0.1%)
Multiple injuries	1/846 (0.1%)
Neck injury	1/846 (0.1%)
Operative haemorrhage	1/846 (0.1%)
Patella fracture	1/846 (0.1%)
Post procedural complication	3/846 (0.4%)
Post procedural haematoma	1/846 (0.1%)
Post procedural haemorrhage	2/846 (0.2%)
Post-traumatic pain	1/846 (0.1%)
Procedural complication	2/846 (0.2%)
Procedural hypotension	1/846 (0.1%)
Procedural vomiting	1/846 (0.1%)
Rib fracture	2/846 (0.2%)
Spinal compression fracture	5/846 (0.6%)
Tendon rupture	1/846 (0.1%)
Tibia fracture	1/846 (0.1%)
Toxicity to various agents	4/846 (0.5%)
Traumatic haematoma	1/846 (0.1%)
Upper limb fracture	1/846 (0.1%)
Vascular bypass dysfunction	1/846 (0.1%)
Wound dehiscence	1/846 (0.1%)
Investigations
Heart rate irregular	1/846 (0.1%)
Metabolism and nutrition disorders
Dehydration	2/846 (0.2%)
Diabetes mellitus	1/846 (0.1%)
Diabetes mellitus inadequate control	1/846 (0.1%)
Hyperkalaemia	1/846 (0.1%)
Hypokalaemia	2/846 (0.2%)
Hyponatraemia	2/846 (0.2%)
Hypovolaemia	1/846 (0.1%)
Obesity	1/846 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/846 (1.3%)
Arthritis	2/846 (0.2%)
Arthropathy	2/846 (0.2%)
Back pain	3/846 (0.4%)
Bunion	2/846 (0.2%)
Cervical spinal stenosis	3/846 (0.4%)
Costochondritis	1/846 (0.1%)
Crystal arthropathy	1/846 (0.1%)
Exostosis	1/846 (0.1%)
Flank pain	2/846 (0.2%)
Foot deformity	5/846 (0.6%)
Fracture delayed union	1/846 (0.1%)
Intervertebral disc degeneration	2/846 (0.2%)
Intervertebral disc disorder	1/846 (0.1%)
Intervertebral disc protrusion	7/846 (0.8%)
Joint contracture	1/846 (0.1%)
Joint destruction	1/846 (0.1%)
Joint instability	1/846 (0.1%)
Joint range of motion decreased	1/846 (0.1%)
Limb deformity	2/846 (0.2%)
Lumbar spinal stenosis	7/846 (0.8%)
Muscular weakness	1/846 (0.1%)
Musculoskeletal chest pain	1/846 (0.1%)
Osteoarthritis	44/846 (5.2%)
Osteolysis	1/846 (0.1%)
Osteonecrosis	2/846 (0.2%)
Osteoporotic fracture	1/846 (0.1%)
Patellofemoral pain syndrome	1/846 (0.1%)
Pathological fracture	1/846 (0.1%)
Rheumatoid arthritis	73/846 (8.6%)
Rheumatoid nodule	1/846 (0.1%)
Rotator cuff syndrome	4/846 (0.5%)
Spinal column stenosis	2/846 (0.2%)
Spinal osteoarthritis	3/846 (0.4%)
Spondylolisthesis	2/846 (0.2%)
Synovitis	3/846 (0.4%)
Tendonitis	1/846 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/846 (0.1%)
B-cell lymphoma	1/846 (0.1%)
Basal cell carcinoma	4/846 (0.5%)
Benign biliary neoplasm	1/846 (0.1%)
Bladder cancer	1/846 (0.1%)
Breast cancer	7/846 (0.8%)
Breast cancer in situ	1/846 (0.1%)
Breast cancer stage I	1/846 (0.1%)
Cervix carcinoma stage 0	1/846 (0.1%)
Chronic lymphocytic leukaemia	3/846 (0.4%)
Colon cancer	1/846 (0.1%)
Colon cancer metastatic	2/846 (0.2%)
Endometrial cancer	2/846 (0.2%)
Endometrial cancer metastatic	1/846 (0.1%)
Gallbladder cancer	1/846 (0.1%)
Gastric cancer	1/846 (0.1%)
Large granular lymphocytosis	1/846 (0.1%)
Lentigo maligna stage unspecified	1/846 (0.1%)
Lung adenocarcinoma	2/846 (0.2%)
Lung neoplasm	1/846 (0.1%)
Lung neoplasm malignant	2/846 (0.2%)
Lung squamous cell carcinoma stage unspecified	1/846 (0.1%)
Lymphoma	2/846 (0.2%)
Malignant melanoma	5/846 (0.6%)
Malignant melanoma in situ	4/846 (0.5%)
Malignant peritoneal neoplasm	1/846 (0.1%)
Meningioma	1/846 (0.1%)
Metastases to liver	1/846 (0.1%)
Multiple myeloma	1/846 (0.1%)
Neoplasm malignant	1/846 (0.1%)
Nodal marginal zone B-cell lymphoma	1/846 (0.1%)
Non-Hodgkin's lymphoma	4/846 (0.5%)
Non-small cell lung cancer	3/846 (0.4%)
Non-small cell lung cancer stage IIIB	1/846 (0.1%)
Paget's disease of the breast	1/846 (0.1%)
Pancreatic carcinoma	1/846 (0.1%)
Parathyroid tumour benign	1/846 (0.1%)
Prostate cancer	9/846 (1.1%)
Renal cancer	1/846 (0.1%)
Renal neoplasm	1/846 (0.1%)
Squamous cell carcinoma	2/846 (0.2%)
Squamous cell carcinoma of skin	1/846 (0.1%)
T-cell lymphoma	1/846 (0.1%)
Thyroid cancer	1/846 (0.1%)
Tonsil cancer	1/846 (0.1%)
Uterine cancer	1/846 (0.1%)
Uterine leiomyoma	5/846 (0.6%)
Uterine neoplasm	1/846 (0.1%)
Nervous system disorders
Carotid artery stenosis	2/846 (0.2%)
Carpal tunnel syndrome	1/846 (0.1%)
Cerebral haemorrhage	2/846 (0.2%)
Cerebrovascular accident	9/846 (1.1%)
Cervical cord compression	1/846 (0.1%)
Cervical myelopathy	2/846 (0.2%)
Epidural lipomatosis	1/846 (0.1%)
Haemorrhage intracranial	1/846 (0.1%)
Hypertensive encephalopathy	1/846 (0.1%)
Hypoaesthesia	2/846 (0.2%)
Intracranial aneurysm	2/846 (0.2%)
Loss of consciousness	1/846 (0.1%)
Migraine	1/846 (0.1%)
Paresthesia	1/846 (0.1%)
Presyncope	1/846 (0.1%)
Radiculopathy	2/846 (0.2%)
Sciatica	1/846 (0.1%)
Spinal cord compression	1/846 (0.1%)
Subarachnoid haemorrhage	2/846 (0.2%)
Syncope	5/846 (0.6%)
Transient ischaemic attack	7/846 (0.8%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/846 (0.1%)
Psychiatric disorders
Confusional state	2/846 (0.2%)
Depression	2/846 (0.2%)
Mental status changes	1/846 (0.1%)
Suicidal ideation	1/846 (0.1%)
Renal and urinary disorders
Calculus ureteric	1/846 (0.1%)
Nephrolithiasis	5/846 (0.6%)
Obstructive uropathy	1/846 (0.1%)
Renal failure acute	7/846 (0.8%)
Stress urinary incontinence	2/846 (0.2%)
Urinary retention	1/846 (0.1%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/846 (0.1%)
Cervical dysplasia	1/846 (0.1%)
Dysmenorrhoea	1/846 (0.1%)
Endometriosis	1/846 (0.1%)
Female genital tract fistula	1/846 (0.1%)
Menometrorrhagia	1/846 (0.1%)
Menorrhagia	1/846 (0.1%)
Ovarian cyst	2/846 (0.2%)
Ovarian cyst ruptured	1/846 (0.1%)
Uterine prolapse	1/846 (0.1%)
Vaginal haemorrhage	4/846 (0.5%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	4/846 (0.5%)
Asthma	3/846 (0.4%)
Atelectasis	1/846 (0.1%)
Bronchitis chronic	1/846 (0.1%)
Bronchopleural fistula	1/846 (0.1%)
Chronic obstructive pulmonary disease	8/846 (0.9%)
Dyspnoea	4/846 (0.5%)
Hydropneumothorax	1/846 (0.1%)
Hypoxia	1/846 (0.1%)
Interstitial lung disease	2/846 (0.2%)
Pleural effusion	4/846 (0.5%)
Pleural fibrosis	1/846 (0.1%)
Pleurisy	1/846 (0.1%)
Pneumonia aspiration	2/846 (0.2%)
Pneumothorax	2/846 (0.2%)
Pulmonary embolism	1/846 (0.1%)
Pulmonary fibrosis	2/846 (0.2%)
Respiratory failure	2/846 (0.2%)
Skin and subcutaneous tissue disorders
Cutis laxa	1/846 (0.1%)
Dermatitis allergic	1/846 (0.1%)
Pyoderma gangrenosum	1/846 (0.1%)
Surgical and medical procedures
Colostomy closure	1/846 (0.1%)
Foot operation	1/846 (0.1%)
Hip arthroplasty	2/846 (0.2%)
Knee arthroplasty	2/846 (0.2%)
Leg amputation	1/846 (0.1%)
Spinal decompression	1/846 (0.1%)
Vascular disorders
Aortic aneurysm	2/846 (0.2%)
Aortic stenosis	1/846 (0.1%)
Deep vein thrombosis	4/846 (0.5%)
Hypotension	3/846 (0.4%)
Jugular vein thrombosis	1/846 (0.1%)
Peripheral artery aneurysm	1/846 (0.1%)
Phlebitis	1/846 (0.1%)
Thrombosis	2/846 (0.2%)
Other (Not Including Serious) Adverse Events
	Adalimumab
	Affected / at Risk (%)	# Events
Total	768/846 (90.8%)
Blood and lymphatic system disorders
Anaemia	62/846 (7.3%)
Eye disorders
Cataract	71/846 (8.4%)
Gastrointestinal disorders
Abdominal pain	48/846 (5.7%)
Abdominal pain upper	52/846 (6.1%)
Constipation	57/846 (6.7%)
Diarrhoea	134/846 (15.8%)
Dyspepsia	60/846 (7.1%)
Gastrooesophageal reflux disease	88/846 (10.4%)
Nausea	119/846 (14.1%)
Vomiting	52/846 (6.1%)
General disorders
Fatigue	107/846 (12.6%)
Injection site pain	56/846 (6.6%)
Oedema peripheral	91/846 (10.8%)
Pyrexia	46/846 (5.4%)
Infections and infestations
Bronchitis	179/846 (21.2%)
Cystitis	46/846 (5.4%)
Gastroenteritis viral	59/846 (7%)
Herpes zoster	90/846 (10.6%)
Influenza	87/846 (10.3%)
Localised infection	46/846 (5.4%)
Nasopharyngitis	193/846 (22.8%)
Oral herpes	48/846 (5.7%)
Pneumonia	63/846 (7.4%)
Sinusitis	211/846 (24.9%)
Tooth abscess	49/846 (5.8%)
Upper respiratory tract infection	392/846 (46.3%)
Urinary tract infection	170/846 (20.1%)
Vulvovaginal mycotic infection	57/846 (6.7%)
Injury, poisoning and procedural complications
Contusion	73/846 (8.6%)
Fall	55/846 (6.5%)
Joint injury	49/846 (5.8%)
Limb injury	47/846 (5.6%)
Muscle strain	51/846 (6%)
Procedural pain	65/846 (7.7%)
Investigations
Alanine aminotransferase increased	52/846 (6.1%)
Aspartate aminotransferase increased	46/846 (5.4%)
Metabolism and nutrition disorders
Hypercholesterolaemia	76/846 (9%)
Hyperlipidaemia	48/846 (5.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	118/846 (13.9%)
Back pain	147/846 (17.4%)
Bursitis	85/846 (10%)
Muscle spasms	66/846 (7.8%)
Musculoskeletal pain	54/846 (6.4%)
Neck pain	46/846 (5.4%)
Osteoarthritis	59/846 (7%)
Osteoporosis	64/846 (7.6%)
Pain in extremity	88/846 (10.4%)
Rheumatoid arthritis	215/846 (25.4%)
Nervous system disorders
Dizziness	90/846 (10.6%)
Headache	104/846 (12.3%)
Hypoaesthesia	43/846 (5.1%)
Psychiatric disorders
Anxiety	74/846 (8.7%)
Depression	105/846 (12.4%)
Insomnia	93/846 (11%)
Respiratory, thoracic and mediastinal disorders
Cough	124/846 (14.7%)
Dyspnoea	54/846 (6.4%)
Oropharyngeal pain	70/846 (8.3%)
Skin and subcutaneous tissue disorders
Rash	131/846 (15.5%)
Vascular disorders
Hypertension	176/846 (20.8%)

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.