Trial Outcomes & Findings for A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department (NCT NCT01411215)

NCT ID: NCT01411215

Last Updated: 2014-03-06

Results Overview

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

• Recruitment status: TERMINATED
• Target enrollment: 160 participants
• Primary outcome timeframe: First day of receiving etanercept through 24 weeks
• Results posted on: 2014-03-06

Participant Flow

Participant milestones

Measure	Rheumatoid Arthritis [RA] Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Overall Study STARTED	69	91
Overall Study Treated	69	90
Overall Study COMPLETED	3	7
Overall Study NOT COMPLETED	66	84

Reasons for withdrawal

Measure	Rheumatoid Arthritis [RA] Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	2	4
Overall Study Lost to Follow-up	12	18
Overall Study Did not meet entrance criteria	0	1
Overall Study Study terminated by sponsor	2	15
Overall Study Protocol Violation	3	5
Overall Study Withdrawal by Subject	34	21
Overall Study Other	12	17
Overall Study Screen failure	0	1

Baseline Characteristics

A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Total n=159 Participants Total of all reporting groups
Age, Customized less than (<) 20 years	3 Participants n=93 Participants	15 Participants n=4 Participants	18 Participants n=27 Participants
Age, Customized greater than or equal to (>=) 20 and <30 years	3 Participants n=93 Participants	27 Participants n=4 Participants	30 Participants n=27 Participants
Age, Customized >=30 and <40 years	7 Participants n=93 Participants	21 Participants n=4 Participants	28 Participants n=27 Participants
Age, Customized >=40 and <50 years	22 Participants n=93 Participants	18 Participants n=4 Participants	40 Participants n=27 Participants
Age, Customized >=50 years	34 Participants n=93 Participants	9 Participants n=4 Participants	43 Participants n=27 Participants
Sex: Female, Male Female	50 Participants n=93 Participants	24 Participants n=4 Participants	74 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	66 Participants n=4 Participants	85 Participants n=27 Participants

PRIMARY outcome

Timeframe: First day of receiving etanercept through 24 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks	7 Participants	9 Participants

PRIMARY outcome

Timeframe: First day of receiving etanercept through 52 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants Who Had Any AEs During 52 Weeks	8 Participants	9 Participants

PRIMARY outcome

Timeframe: Informed consent or signed data privacy statement through 24 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Informed consent or signed data privacy statement through 52 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants Who Had Any SAEs During 52 Weeks	0 Participants	0 Participants

PRIMARY outcome

Timeframe: First day of receiving etanercept through 24 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants With AEs Per System Organ Class During 24 Weeks Eye disorders	0 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Gastrointestinal disorders	0 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks General disorders+administration site conditions	2 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Hepatobiliary disorders	0 Participants	2 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Investigations	3 Participants	3 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Metabolism and nutrition disorders	1 Participants	0 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Musculoskeletal and connective tissue disorders	0 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Skin and subcutaneous tissue disorders	2 Participants	0 Participants
Number of Participants With AEs Per System Organ Class During 24 Weeks Infections and infestations	1 Participants	1 Participants

PRIMARY outcome

Timeframe: First day of receiving etanercept through 52 weeks

Population: All enrolled participants who received at least 1 dose of etanercept.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants With AEs Per System Organ Class During 52 Weeks Eye disorders	0 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Gastrointestinal disorders	0 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks General disorders+administration site conditions	2 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Hepatobiliary disorders	0 Participants	2 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Infections and infestations	1 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Metabolism and nutrition disorders	1 Participants	0 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Musculoskeletal and connective tissue disorders	1 Participants	1 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Skin and subcutaneous tissue disorders	2 Participants	0 Participants
Number of Participants With AEs Per System Organ Class During 52 Weeks Investigations	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician's global assessment of disease activity. n=number of evaluable participants at the corresponding visit.

Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=65 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=82 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Physician's Global Assessment of Disease Activity Week 4, n=35,61	40.5 mm Standard Deviation 30.77	44.2 mm Standard Deviation 31.23
Physician's Global Assessment of Disease Activity Week 8, n=24,47	34.8 mm Standard Deviation 37.39	43.9 mm Standard Deviation 30.76
Physician's Global Assessment of Disease Activity Week 12, n=16,34	34.8 mm Standard Deviation 35.22	39.2 mm Standard Deviation 35.88
Physician's Global Assessment of Disease Activity Week 24, n=7,18	27.4 mm Standard Deviation 35.18	30.1 mm Standard Deviation 30.78
Physician's Global Assessment of Disease Activity Week 36, n=2,13	5.0 mm Standard Deviation 7.07	19.8 mm Standard Deviation 26.49
Physician's Global Assessment of Disease Activity Week 52, n=3,6	10.7 mm Standard Deviation 15.14	16.5 mm Standard Deviation 12.08
Physician's Global Assessment of Disease Activity Baseline (Week 0), n=65,82	63.4 mm Standard Deviation 20.62	60.9 mm Standard Deviation 22.91
Physician's Global Assessment of Disease Activity Week 2, n=44,59	45.3 mm Standard Deviation 26.33	48.2 mm Standard Deviation 29.14

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit.

Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=65 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=84 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Participant's Global Assessment (PtGA) of Disease Activity Week 2, n=42,61	45.1 mm Standard Deviation 27.00	48.9 mm Standard Deviation 27.52
Participant's Global Assessment (PtGA) of Disease Activity Week 4, n=35, 60	42.2 mm Standard Deviation 31.16	44.1 mm Standard Deviation 30.78
Participant's Global Assessment (PtGA) of Disease Activity Week 8, n=23, 47	36.1 mm Standard Deviation 38.10	44.4 mm Standard Deviation 31.25
Participant's Global Assessment (PtGA) of Disease Activity Week 24, n=7,18	26.6 mm Standard Deviation 35.02	32.1 mm Standard Deviation 32.72
Participant's Global Assessment (PtGA) of Disease Activity Week 36, n=2,12	5.0 mm Standard Deviation 7.07	13.5 mm Standard Deviation 12.92
Participant's Global Assessment (PtGA) of Disease Activity Week 52, n=3,6	12.7 mm Standard Deviation 20.23	22.5 mm Standard Deviation 16.40
Participant's Global Assessment (PtGA) of Disease Activity Baseline (Week 0), n=65, 84	64.9 mm Standard Deviation 20.27	61.8 mm Standard Deviation 21.50
Participant's Global Assessment (PtGA) of Disease Activity Week 12, n=16,33	34.6 mm Standard Deviation 35.19	38.8 mm Standard Deviation 35.54

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit.

Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=65 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=84 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
VAS Score for Pain Week 2, n=42,62	42.7 mm Standard Deviation 27.90	47.4 mm Standard Deviation 28.63
VAS Score for Pain Week 4, n=35,60	41.0 mm Standard Deviation 32.31	42.7 mm Standard Deviation 31.08
VAS Score for Pain Week 24, n=7,18	27.0 mm Standard Deviation 36.52	30.0 mm Standard Deviation 30.04
VAS Score for Pain Week 36, n=2,13	5.0 mm Standard Deviation 7.07	20.0 mm Standard Deviation 26.97
VAS Score for Pain Week 48, n=3,6	13.7 mm Standard Deviation 18.72	17.2 mm Standard Deviation 15.09
VAS Score for Pain Baseline (Week 0), n=65,84	64.8 mm Standard Deviation 19.56	60.5 mm Standard Deviation 23.38
VAS Score for Pain Week 8, n=23,47	35.2 mm Standard Deviation 38.28	41.7 mm Standard Deviation 31.39
VAS Score for Pain Week 12, n=16,34	35.6 mm Standard Deviation 35.50	39.7 mm Standard Deviation 36.57

SECONDARY outcome

Timeframe: First day of receiving etanercept up to Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded.

Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=88 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% <50%	3 Participants	3 Participants
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% >= 50% and <70%	40 Participants	44 Participants
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% >=70% and <80%	4 Participants	0 Participants
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% >=80% and <100%	4 Participants	4 Participants
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% >=120%	0 Participants	1 Participants
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% >=100% and <120%	18 Participants	36 Participants

SECONDARY outcome

Timeframe: First day of receiving etanercept up to Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group.

Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=69 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=88 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (<50%), n=3,15	1 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (>=50% and <70%), n=3,15	2 Participants	11 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (>=70% and <80%), n=3,15	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (>=80% and <100%), n=3,15	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (>=100% and <120%), n=3,15	0 Participants	4 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate <20 years (>=120%), n=3,15	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (<50%), n=3,26	0 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (>=50% and <70%), n=3,26	3 Participants	14 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (>=70% and <80%), n=3,26	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (>=80% and <100%), n=3,26	0 Participants	2 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (>=100% and <120%), n=3,26	0 Participants	9 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (<50%), n=7,21	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (>=50% and <70%), n=7,21	3 Participants	9 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (>=70% and <80%), n=7,21	1 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (>=120%), n=7,21	0 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (<50%), n=22,17	0 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (>=70% and <80%), n=22,17	2 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (>=80% and <100%), n=22,17	2 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (>=100% and <120%), n=22,17	5 Participants	7 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (>=120%), n=22,17	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (>=50% and <70%), n=34,9	19 Participants	2 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (>=70% and <80%), n=34,9	1 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (>=100% and <120%), n=34,9	10 Participants	6 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (>=120%), n=34,9	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=20 and <30 years (>=120%), n=3,26	0 Participants	0 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (>=80% and <100%), n=7,21	0 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=30 and <40 years (>=100% and <120%), n=7,21	3 Participants	10 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >=40 and <50 years (>=50% and <70%), n=22,17	13 Participants	8 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (<50%), n=34,9	2 Participants	1 Participants
Evaluate the Association Between Participant's Age and Treatment Adherence Rate >50 years (>=80% and <100%), n=34,9	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities.

Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=37 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=62 Participants Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of Participants With Any Abnormal Laboratory Test Results	25 Participants	34 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit.

TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=68 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Tender Joint Count (TJC) for RA Participants Baseline (Week 0), n=68	10.0 Joints Standard Deviation 7.77	—
Tender Joint Count (TJC) for RA Participants Week 2, n=44	4.0 Joints Standard Deviation 4.72	—
Tender Joint Count (TJC) for RA Participants Week 24, n=6	0.7 Joints Standard Deviation 1.21	—
Tender Joint Count (TJC) for RA Participants Week 36, n=2	0.0 Joints Standard Deviation 0.00	—
Tender Joint Count (TJC) for RA Participants Week 4, n=34	2.9 Joints Standard Deviation 4.02	—
Tender Joint Count (TJC) for RA Participants Week 8, n=22	1.7 Joints Standard Deviation 4.31	—
Tender Joint Count (TJC) for RA Participants Week 12, n=17	2.0 Joints Standard Deviation 4.76	—
Tender Joint Count (TJC) for RA Participants Week 52, n=3	2.0 Joints Standard Deviation 1.73	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit.

SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=68 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Swollen Joint Count (SJC) for RA Participants Baseline (Week 0), n=68	5.5 Joints Standard Deviation 5.75	—
Swollen Joint Count (SJC) for RA Participants Week 2, n=44	2.3 Joints Standard Deviation 3.07	—
Swollen Joint Count (SJC) for RA Participants Week 4, n=34	1.5 Joints Standard Deviation 2.54	—
Swollen Joint Count (SJC) for RA Participants Week 8, n=22	0.3 Joints Standard Deviation 0.72	—
Swollen Joint Count (SJC) for RA Participants Week 12, n=17	0.5 Joints Standard Deviation 0.94	—
Swollen Joint Count (SJC) for RA Participants Week 24, n=6	0.2 Joints Standard Deviation 0.41	—
Swollen Joint Count (SJC) for RA Participants Week 36, n=2	0.0 Joints Standard Deviation 0.00	—
Swollen Joint Count (SJC) for RA Participants Week 52, n=3	0.3 Joints Standard Deviation 0.58	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=55 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 8, n=1	2.88 units on a scale Standard Deviation NA Standard deviation cannot be calculated since only 1 participant was analyzed at this visit.	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 12, n=8	2.80 units on a scale Standard Deviation 1.702	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 36, n=1	1.20 units on a scale Standard Deviation NA Standard deviation cannot be calculated since only 1 participant was analyzed at this visit.	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 52, n=2	3.08 units on a scale Standard Deviation 2.083	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Baseline (Week 0), n=55	5.57 units on a scale Standard Deviation 1.338	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 2, n=20	4.03 units on a scale Standard Deviation 1.305	—
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 4, n=18	3.31 units on a scale Standard Deviation 1.453	—

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit.

Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=17 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 2), n=17	4 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 2), n=17	10 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 2), n=17	3 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 4), n=16	6 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 8), n=1	1 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 8), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 8), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 12), n=7	5 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 12), n=7	2 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 12), n=7	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 36), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Moderate response (Week 52), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 52), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 4), n=16	8 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 4), n=16	2 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 36), n=1	1 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement No response (Week 36), n=1	0 Participants	—
Number of RA Participants Had DAS28-4 (ESR) Improvement Good response (Week 52), n=1	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52

Population: All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.

Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.

Outcome measures

Measure	Rheumatoid Arthritis [RA] n=55 Participants Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Number of RA Participants Had Remission of Disease Baseline (Week 0), n=55	0 Participants	—
Number of RA Participants Had Remission of Disease Week 2, n=20	2 Participants	—
Number of RA Participants Had Remission of Disease Week 8, n=1	0 Participants	—
Number of RA Participants Had Remission of Disease Week 12, n=8	4 Participants	—
Number of RA Participants Had Remission of Disease Week 36, n=1	1 Participants	—
Number of RA Participants Had Remission of Disease Week 52, n=2	1 Participants	—
Number of RA Participants Had Remission of Disease Week 4, n=18	5 Participants	—

Adverse Events

Rheumatoid Arthritis [RA]

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Ankylosing Spondylitis [AS]

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rheumatoid Arthritis [RA] n=69 participants at risk Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	Ankylosing Spondylitis [AS] n=90 participants at risk Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
Eye disorders Uveitis	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Injection site swelling	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Irritability	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase abnormal	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	2.9% 2/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Drug eruption	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	1.4% 1/69 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/90 • First day of receiving etanercept through the study period until at least 28 after the last dose of etanercept, for SAE, the start time was when the subject provided informed consent or signed data privacy statement. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER