Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01163916
• Collaborator: Scientific Research Institute of Rheumatology, Moscow (Other), Almedis (Industry)
• Enrollment: 252
• Locations: 43
• Duration (Months): 46
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Detailed Description

This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.

The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.

Study Design

• Study Type: Observational
• Actual Enrollment: 252 participants
• Time Perspective: Prospective
• Official Title: A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Patients with RA, PsA and AS Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia.

Outcome Measures

Primary Outcome Measures

1. Characteristics of Patients Prescribed Adalimumab: Education Level [Baseline]

   Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.

2. Characteristics of Patients Prescribed Adalimumab: Occupation [Baseline]

   Participants were asked to indicate their occupation at the Baseline visit.

3. Characteristics of Patients Prescribed Adalimumab: Residence Status [Baseline]

   Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.

4. Characteristics of Patients Prescribed Adalimumab: Marital Status [Baseline]

   Participants were asked to indicate their marital status at the Baseline visit.

5. Characteristics of Patients Prescribed Adalimumab: Disease Severity [Baseline]

   Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.

6. Characteristics of Patients Prescribed Adalimumab: Duration of Disease [Baseline]

   Duration of disease was defined as the time from diagnosis until study entry.

7. Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment [Baseline and at each follow-up visit (up to a maximum of 18.2 months).]

   Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.

Secondary Outcome Measures

1. Patient's Acceptability of Self-injections [Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.]

   At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject." The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice. Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.

2. Percentage of Participants With Missed or Delayed Injections [For the duration of the study (up to a maximum of 18.2 months).]

   Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.

3. Duration of Treatment With Adalimumab [For the duration of the study (up to a maximum of 18.2 months).]

   Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:

• Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.

• Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.

Exclusion Criteria:

The following patients will not be included in the study:

• Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.

• Hypersensitivity to adalimumab

• Pregnancy

• Lactation

• Age below 18

• Infectious diseases including tuberculosis

• Patients currently participating in another clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Ref # / Investigator 50728	Belgorod		Russian Federation	308007
2	Site Ref # / Investigator 50737	Chelyabinsk		Russian Federation	454047
3	Site Reference ID/Investigator# 6002	Ekaterinburg		Russian Federation	620000
4	Site Ref # / Investigator 50731	Izhevsk		Russian Federation	426009
5	Site Reference ID/Investigator# 29084	Kaliningrad		Russian Federation	236000
6	Site Ref # / Investigator 50746	Khanty Mansisk		Russian Federation	628600
7	Site Reference ID/Investigator# 29163	Khanty-Mansiysk		Russian Federation	626200
8	Site Ref # / Investigator 50736	Krasnogorsk		Russian Federation	143420
9	Site Ref # / Investigator 50727	Lipetsk		Russian Federation	308036
10	Site Ref # / Investigator 50723	Moscow		Russian Federation	105203
11	Site Ref # / Investigator 50725	Moscow		Russian Federation	105229
12	Site Ref # / Investigator 50742	Moscow		Russian Federation	109451
13	Site Ref # / Investigator 50743	Moscow		Russian Federation	109451
14	Site Ref # / Investigator 50724	Moscow		Russian Federation	115682
15	Site Ref # / Investigator 50739	Moscow		Russian Federation	121356
16	Site Ref # / Investigator 50732	Moscow		Russian Federation	123060
17	Site Ref # / Investigator 50738	Moscow		Russian Federation	123098
18	Site Ref # / Investigator 50744	Moscow		Russian Federation	123308
19	Site Reference ID/Investigator# 28989	Moscow		Russian Federation	125009
20	Site Reference ID/Investigator# 28990	Moscow		Russian Federation	125009
21	Site Reference ID/Investigator# 29195	Moscow		Russian Federation	125009
22	Site Reference ID/Investigator# 29482	Moscow		Russian Federation	125009
23	Site Reference ID/Investigator# 29483	Moscow		Russian Federation	125009
24	Site Ref # / Investigator 50740	Moscow		Russian Federation	127206
25	Site Ref # / Investigator 50733	Moscow		Russian Federation	127473
26	Site Ref # / Investigator 50745	Moscow		Russian Federation	127543
27	Site Ref # / Investigator 50741	Moscow		Russian Federation	127642
28	Site Reference ID/Investigator# 28956	Nizhnevartovsk		Russian Federation	628600
29	Site Reference ID/Investigator# 28968	Perm		Russian Federation	614014
30	Site Reference ID/Investigator# 28969	Perm		Russian Federation	614014
31	Site Reference ID/Investigator# 32403	Saint Petersburg		Russian Federation	191015
32	Site Ref # / Investigator 50729	Salekhard		Russian Federation	629001
33	Site Reference ID/Investigator# 28957	St. Petersburg		Russian Federation	190000
34	Site Reference ID/Investigator# 28997	St. Petersburg		Russian Federation	190000
35	Site Reference ID/Investigator# 28999	St. Petersburg		Russian Federation	190000
36	Site Reference ID/Investigator# 29001	St. Petersburg		Russian Federation	190000
37	Site Reference ID/Investigator# 29008	Surgut		Russian Federation	628400
38	Site Reference ID/Investigator# 32404	Tula		Russian Federation	300036
39	Site Reference ID/Investigator# 29095	Ulyanovsk		Russian Federation	432000
40	Site Ref # / Investigator 50734	V. Novgorod		Russian Federation	173008
41	Site Ref # / Investigator 50730	Vologda		Russian Federation	160001
42	Site Ref # / Investigator 50735	Voronezh		Russian Federation	394024
43	Site Ref # / Investigator 50726	Voronezh		Russian Federation	394082

Sponsors and Collaborators

• Abbott
• Scientific Research Institute of Rheumatology, Moscow
• Almedis

Investigators

• Study Director: Andrey N Strugovschikov, MD, Abbott Russia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01163916
• Other Study ID Numbers: P10-272
• First Posted: Jul 16, 2010
• Last Update Posted: Dec 7, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Abbott: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
• Additional relevant MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic; Spondylitis, Ankylosing

Study Results

Participant Flow

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Period Title: Overall Study
STARTED	126	35	91
Safety Population	125	35	91
COMPLETED	96	31	71
NOT COMPLETED	30	4	20

Baseline Characteristics

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis	Total
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Total of all reporting groups
Overall Participants	126	35	91	252
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.0 (13.7)	42.4 (12.6)	36.2 (10.6)	42.5 (13.4)
Sex: Female, Male (Count of Participants)
Female	93 73.8%	18 51.4%	23 25.3%	134 53.2%
Male	33 26.2%	17 48.6%	68 74.7%	118 46.8%
Region of Enrollment (participants) [Number]
Russian Federation	126 100%	35 100%	91 100%	252 100%

Outcome Measures

1. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Education Level
Description	Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	126	35	91
Secondary school	21 16.7%	2 5.7%	5 5.5%
Vocational school/college	34 27%	9 25.7%	26 28.6%
University degree	64 50.8%	19 54.3%	51 56%
Current university student	5 4%	5 14.3%	8 8.8%
Other	2 1.6%	0 0%	1 1.1%

2. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Occupation
Description	Participants were asked to indicate their occupation at the Baseline visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	126	35	91
Blue collar worker	13 10.3%	5 14.3%	10 11%
Civil servant	10 7.9%	5 14.3%	12 13.2%
White collar worker	52 41.3%	13 37.1%	38 41.8%
Self-employed	8 6.3%	1 2.9%	9 9.9%
Student	7 5.6%	4 11.4%	4 4.4%
Retired	21 16.7%	4 11.4%	4 4.4%
Other	15 11.9%	3 8.6%	14 15.4%

3. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Residence Status
Description	Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	126	35	91
Permanent	113 89.7%	33 94.3%	88 96.7%
Temporary	13 10.3%	2 5.7%	3 3.3%

4. Secondary Outcome

Title	Patient's Acceptability of Self-injections
Description	At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject." The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice. Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.
Time Frame	Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.

Outcome Measure Data

Analysis Population Description

The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.

Arm/Group Title	Convenient	Not Convenient	Need Assistance	Missing
Arm/Group Description	Participants who described the acceptability of adalimumab injections as "convenient."	Participants who described the acceptability of adalimumab injections as "not convenient."	Participants who were unable to self-inject.	Participants for whom acceptability data were not available.
Measure Participants	251	251	251	251
Visit 1: 40 mg every other week	168 133.3%	10 28.6%	71 78%	0 0%
Visit 1: 40 mg once a week	0 0%	0 0%	0 0%	0 0%
Visit 2: 40 mg every other week	172 136.5%	7 20%	63 69.2%	0 0%
Visit 2: 40 mg once a week	1 0.8%	0 0%	1 1.1%	0 0%
Visit 2: Missing regimen data	2 1.6%	0 0%	0 0%	0 0%
Visit 3: 40 mg every other week	177 140.5%	7 20%	49 53.8%	0 0%
Visit 3: 40 mg once a week	0 0%	0 0%	0 0%	0 0%
Visit 3: Missing regimen data	4 3.2%	0 0%	0 0%	0 0%
Visit 4: 40 mg every other week	155 123%	3 8.6%	45 49.5%	0 0%
Visit 4: 40 mg once a week	0 0%	0 0%	0 0%	0 0%
Visit 4: Missing regimen data	2 1.6%	0 0%	0 0%	0 0%
Visit 5: 40 mg every other week	137 108.7%	1 2.9%	39 42.9%	0 0%
Visit 5: 40 mg once a week	0 0%	0 0%	0 0%	0 0%
Visit 5: Missing regimen data	0 0%	0 0%	1 1.1%	1 0.4%
Visit 6: 40 mg every other week	105 83.3%	1 2.9%	27 29.7%	0 0%
Visit 6: 40 mg once a week	1 0.8%	0 0%	0 0%	0 0%
Visit 6: Missing regimen data	0 0%	0 0%	0 0%	1 0.4%

5. Secondary Outcome

Title	Percentage of Participants With Missed or Delayed Injections
Description	Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
Time Frame	For the duration of the study (up to a maximum of 18.2 months).

Outcome Measure Data

Analysis Population Description

Safety set; the analysis only includes participants with non-missing data.

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	125	35	90
No missed or delayed injections	55.2 43.8%	57.1 163.1%	56.7 62.3%
One missed or delayed injection	21.6 17.1%	11.4 32.6%	21.1 23.2%
Two missed or delayed injections	9.6 7.6%	20.0 57.1%	7.8 8.6%
Three or more missed or delayed injections	13.6 10.8%	11.4 32.6%	14.4 15.8%

6. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Marital Status
Description	Participants were asked to indicate their marital status at the Baseline visit.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	126	35	91
Married	94 74.6%	24 68.6%	69 75.8%
Single	32 25.4%	11 31.4%	21 23.1%
Missing	0 0%	0 0%	1 1.1%

7. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Disease Severity
Description	Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Safety set.

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	125	35	91
Mild	0 0%	2 5.7%	0 0%
Moderate	44 34.9%	14 40%	31 34.1%
Severe	81 64.3%	19 54.3%	60 65.9%

8. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Description	Duration of disease was defined as the time from diagnosis until study entry.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	125	35	91
Median (Full Range) [months]	71.70 (81.91)	103.50 (110.02)	50.90 (79.47)

9. Primary Outcome

Title	Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Description	Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Time Frame	Baseline and at each follow-up visit (up to a maximum of 18.2 months).

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	125	35	91
Methotrexate	96 76.2%	23 65.7%	20 22%
NSAIDs	73 57.9%	16 45.7%	72 79.1%
Corticosteroids	48 38.1%	9 25.7%	16 17.6%
Other medications	82 65.1%	18 51.4%	65 71.4%

10. Secondary Outcome

Title	Duration of Treatment With Adalimumab
Description	Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.
Time Frame	For the duration of the study (up to a maximum of 18.2 months).

Outcome Measure Data

Analysis Population Description

Safety set.

Arm/Group Title	Rheumatoid Arthritis	Psoriatic Arthritis	Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Measure Participants	125	35	91
Median (Full Range) [weeks]	52.10	52.90	52.30

Adverse Events

Time Frame	Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.
Arm/Group Title	Rheumatoid Arthritis		Psoriatic Arthritis		Ankylosing Spondylitis
Arm/Group Description	Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.		Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.		Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
All Cause Mortality
	Rheumatoid Arthritis		Psoriatic Arthritis		Ankylosing Spondylitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Rheumatoid Arthritis		Psoriatic Arthritis		Ankylosing Spondylitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/125 (1.6%)		0/35 (0%)		0/91 (0%)
Infections and infestations
Bacteraemia	1/125 (0.8%)		0/35 (0%)		0/91 (0%)
Purulent discharge	1/125 (0.8%)		0/35 (0%)		0/91 (0%)
Injury, poisoning and procedural complications
Wound necrosis	1/125 (0.8%)		0/35 (0%)		0/91 (0%)
Other (Not Including Serious) Adverse Events
	Rheumatoid Arthritis		Psoriatic Arthritis		Ankylosing Spondylitis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/125 (7.2%)		0/35 (0%)		8/91 (8.8%)
Infections and infestations
Respiratory tract infection viral	9/125 (7.2%)		0/35 (0%)		8/91 (8.8%)

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.