Trial Outcomes & Findings for Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg (NCT NCT00195338)
NCT ID: NCT00195338
Last Updated: 2012-01-23
Results Overview
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Recruitment status
COMPLETED
Target enrollment
25 participants
Primary outcome timeframe
Baseline up to Month 66
Results posted on
2012-01-23
Participant Flow
Participant milestones
| Measure |
Etanercept
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Etanercept
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Early closure of the site
|
4
|
Baseline Characteristics
Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Baseline characteristics by cohort
| Measure |
Etanercept
n=25 Participants
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Age Continuous
|
50.20 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 66Population: Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Etanercept
n=25 Participants
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
56 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
24 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12 through Month 72Population: FAS included all recruited participants who were either initiated or were already receiving etanercept.
Outcome measures
| Measure |
Etanercept
n=25 Participants
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Percentage of Participants With Completion of Study Treatment
12 to 18 months
|
100 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 18 months to 24 months
|
100 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 24 months to 30 months
|
92 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 30 months to 36 months
|
80 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 36 months to 42 months
|
80 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 42 months to 48 months
|
80 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 48 months to 54 months
|
68 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 54 months to 60 months
|
52 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 60 months to 66 months
|
28 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 66 months to 72 months
|
12 percentage of participants
|
|
Percentage of Participants With Completion of Study Treatment
Greater than 72 months
|
12 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 18, 30, 42, 54 and 66Population: FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.
Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.
Outcome measures
| Measure |
Etanercept
n=25 Participants
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Baseline
|
26.5 joints
Standard Deviation 15.7
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 6 (n= 14)
|
-20.2 joints
Standard Deviation 15.8
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 12 (n= 15)
|
-20.3 joints
Standard Deviation 14.1
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 18 (n= 19)
|
-21.4 joints
Standard Deviation 15.2
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 30 (n= 22)
|
-19.5 joints
Standard Deviation 16.7
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 42 (n= 20)
|
-24.4 joints
Standard Deviation 16.3
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 54 (n= 18)
|
-24.3 joints
Standard Deviation 16.2
|
|
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 66 (n= 13)
|
-22.8 joints
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, 18, 30, 42, 54 and 66Population: FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty = 0), 'adequate' (some difficulty = 1), 'limited' (much difficulty = 2), and 'unable to do' (= 3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total possible score ranged from 0 (no difficulty) to 60 (unable to do).
Outcome measures
| Measure |
Etanercept
n=18 Participants
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Baseline
|
32.4 units on a scale
Standard Deviation 12.0
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 6 (n= 6)
|
-13.7 units on a scale
Standard Deviation 8.4
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 12 (n= 9)
|
-17.0 units on a scale
Standard Deviation 7.5
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 18 (n= 10)
|
-17.8 units on a scale
Standard Deviation 9.8
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 30 (n= 11)
|
-10.4 units on a scale
Standard Deviation 14.5
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 42 (n= 9)
|
-20.0 units on a scale
Standard Deviation 15.3
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 54 (n= 8)
|
-16.6 units on a scale
Standard Deviation 14.3
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
Change at Month 66 (n= 2)
|
-26.5 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline up to Month 66Population: Data was not analyzed due to low number of participants.
Outcome measures
Outcome data not reported
Adverse Events
Etanercept
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=25 participants at risk
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
General disorders
Angioneurotic oedema
|
4.0%
1/25
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
Myocardial infarction
|
4.0%
1/25
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
Leucopenia
|
4.0%
1/25
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
Neutropenia
|
4.0%
1/25
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
Liver function test abnormal
|
4.0%
1/25
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
Knee arthroplasty
|
4.0%
1/25
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
Breast cancer
|
4.0%
1/25
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.
|
Other adverse events
| Measure |
Etanercept
n=25 participants at risk
Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
|
|---|---|
|
General disorders
Allergy
|
4.0%
1/25
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
Fatigue
|
20.0%
5/25
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
General discomfort with hypotension
|
4.0%
1/25
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 reaction
|
8.0%
2/25
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
Sleep Trouble
|
4.0%
1/25
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
Vertigo
|
4.0%
1/25
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
Fracture left clavicle
|
4.0%
1/25
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
Osteoporosis fractures
|
4.0%
1/25
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
Synoviorthesis knee
|
4.0%
1/25
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
High blood pressure
|
4.0%
1/25
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
Constipation
|
8.0%
2/25
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
Diarrhea
|
8.0%
2/25
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
Flatulence
|
4.0%
1/25
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
Increased hepatic enzymes
|
4.0%
1/25
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
Rectorragies
|
4.0%
1/25
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
Increased intra-ocular pressure
|
4.0%
1/25
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
Ocular dryness
|
4.0%
1/25
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
Aphtosis
|
4.0%
1/25
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
Buccal dryness
|
4.0%
1/25
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
Hypersensitivity tooth
|
4.0%
1/25
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
Bronchopneumopathy recurrent
|
4.0%
1/25
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
Dyspnea
|
4.0%
1/25
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
Pulmonary oedema
|
4.0%
1/25
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
Laryngitis
|
4.0%
1/25
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
Sinusitis
|
4.0%
1/25
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
Pruritus
|
4.0%
1/25
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
Nose and skin bleeding
|
4.0%
1/25
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
Zona
|
4.0%
1/25
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
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