Trial Outcomes & Findings for REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®) (NCT NCT00127842)

Last Updated: 2014-04-24

Results Overview

The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

Baseline and 24 months

Results posted on

2014-04-24

Participant Flow

Participants were enrolled from 5 August 2005 through 2 February 2007

Participant milestones

Participant milestones
Measure	Enbrel Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Overall Study STARTED	110
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Enbrel Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Overall Study Adverse Event	15
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	12
Overall Study Noncompliance	2
Overall Study Protocol Violation	1
Overall Study Other	5

Baseline Characteristics

REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enbrel n=110 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Age, Continuous	48.4 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	1 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Canadian Aboriginal	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	103 Participants n=5 Participants
Health and Labour Questionnaire (HLQ) Absence from Work Module	0.8 days STANDARD_DEVIATION 2.51 • n=5 Participants
HLQ Reduced Productivity at Paid Work Module	2.3 Hours STANDARD_DEVIATION 8.22 • n=5 Participants
HLQ Unpaid Work Module: Help Received with Unpaid Work Unpaid help	7.7 Hours STANDARD_DEVIATION 10.20 • n=5 Participants
HLQ Unpaid Work Module: Help Received with Unpaid Work Paid help	2.2 Hours STANDARD_DEVIATION 9.20 • n=5 Participants
HLQ Impediments to Work Module	3.0 Units on a scale STANDARD_DEVIATION 1.33 • n=5 Participants
Physician Global Assessment	3.23 Units on a scale STANDARD_DEVIATION 0.463 • n=5 Participants
Patient Global Assessment	3.28 Units on a scale STANDARD_DEVIATION 0.559 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 months

Population: Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.

Outcome measures

Outcome measures
Measure	Enbrel n=109 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI	56.0 percentage of participants Interval 46.1 to 65.0

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.

The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=40 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module	0.4 days Standard Deviation 2.64

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).

The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=2 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module	0.0 Hours Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline and month 24

Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). "n" indicates the number of participants who had unpaid or paid help with their unpaid work.

The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=71 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module Unpaid help (n=66)	3.2 Hours Standard Deviation 12.06
Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module Paid help (n=27)	1.9 Hours Standard Deviation 11.39

SECONDARY outcome

Timeframe: Baseline and month 24

Population: Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.

In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=71 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module	1.5 Units on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: Baseline and month 24

The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=110 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in the Physician Global Assessment	0.91 Units on a scale Standard Deviation 0.991

SECONDARY outcome

Timeframe: Baseline and Month 24

The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=110 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Percent Change From Baseline to Month 24 in Physician Global Assessment	27.2 Percentage change Interval -66.7 to 75.0

SECONDARY outcome

Timeframe: Baseline and Month 24

The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=109 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Change From Baseline to Month 24 in Patient Global Assessment	0.59 Units on a scale Standard Deviation 0.874

SECONDARY outcome

Timeframe: Baseline and month 24

The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value \* 100. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Enbrel n=109 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Percent Change From Baseline to Month 24 in Patient Global Assessment	16.4 Percentage change Interval -33.3 to 75.0

SECONDARY outcome

Timeframe: Baseline and Month 24

The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.

Outcome measures

Outcome measures
Measure	Enbrel n=110 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)	41.8 percentage of participants Interval 32.5 to 51.6

SECONDARY outcome

Timeframe: Baseline and Month 24

Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).

Outcome measures

Outcome measures
Measure	Enbrel n=109 Participants Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24	78.9 percentage of participants Interval 70.0 to 86.1

Adverse Events

Enbrel

Serious events: 14 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enbrel n=110 participants at risk Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Cardiac disorders Angina pectoris	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Appendicitis perforated	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical hernia	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Abdominal abscess	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia viral	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Streptococcal infection	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fibula fracture	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tibia fracture	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Scleroderma	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Ovarian cyst	0.91% 1/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Other adverse events
Measure	Enbrel n=110 participants at risk Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Gastrointestinal disorders Diarrhoea	6.4% 7/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Influenza like illness	10.0% 11/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site reaction	11.8% 13/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	18.2% 20/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	9.1% 10/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	13.6% 15/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 6/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	10.9% 12/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 6/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.5% 6/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	6.4% 7/110 • Up to 25 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER