Trial Outcomes & Findings for Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria (NCT NCT01877239)

Last Updated: 2018-12-03

Results Overview

CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low disease activity, greater than (\>) 10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with CDAI remission (score \<=2.8) at Week 24 were reported.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

Week 24

Results posted on

2018-12-03

Participant Flow

A total of 111 participants were enrolled in the study but due to the loss of all study data and material at one site with 35 participants, the number of participants that could be included in the analysis was 76.

Participant milestones

Participant milestones
Measure	Etanercept Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Overall Study STARTED	111
Overall Study Treated	76
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Overall Study Adverse Event	4
Overall Study Disease Remission	1
Overall Study Withdrawal by Subject	4
Overall Study Other	2
Overall Study Lack of Efficacy	4
Overall Study Data not available	35

Baseline Characteristics

Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=76 Participants Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Age, Continuous	54.3 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Eligible Set included all participants who had given written informed consent and had received at least one dose of etanercept with evaluable CDAI assessments at baseline and Week 24.

Outcome measures

Outcome measures
Measure	Etanercept n=61 Participants Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24	44.3 percentage of participants Interval 31.53 to 57.56

SECONDARY outcome

Timeframe: Week 12 and Week 52

Population: FAS included any participants who had given written informed consent.

CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Etanercept n=76 Participants Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Remission At Week 12	22.4 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Low disease activity At Week 12	50.0 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Moderate disease activity At Week 12	11.8 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 High disease activity At Week 12	2.6 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Remission At Week 52	48.7 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Low disease activity At Week 52	19.7 percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 Moderate disease activity At Week 52	7.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

Population: FAS included any participants who had given written informed consent. Here, "number analyzed" signifies participants who were evaluable at specified categories.

Outcome measures

Outcome measures
Measure	Etanercept n=76 Participants Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 Baseline	25.75 units on a scale Standard Deviation 8.195
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 Change at Week 12	-19.09 units on a scale Standard Deviation 7.903
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 Change at Week 24	-20.45 units on a scale Standard Deviation 8.746
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 Change at Week 52	-22.58 units on a scale Standard Deviation 7.732

Adverse Events

Etanercept

Serious events: 8 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept n=76 participants at risk Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Cardiac disorders Atrial fibrillation	2.6% 2/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Disease recurrence	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Borrelia infection	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ligament injury	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Haematoma	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Other adverse events

Other adverse events
Measure	Etanercept n=76 participants at risk Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection.
Cardiac disorders Atrial fibrillation	2.6% 2/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Disease recurrence	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Drug ineffective	5.3% 4/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Injection site erythema	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Injection site rash	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
General disorders Injection site reaction	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Borrelia infection	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Infections and infestations Viral upper respiratory tract infection	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Fall	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Ligament injury	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Injury, poisoning and procedural complications Thoracic vertebral fracture	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Nervous system disorders Headache	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Pruritus	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Skin and subcutaneous tissue disorders Rash	2.6% 2/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Vascular disorders Haematoma	1.3% 1/76 • Baseline up to Week 52 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 participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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