Trial Outcomes & Findings for A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA (NCT NCT00195403)
NCT ID: NCT00195403
Last Updated: 2013-08-15
Results Overview
Any untoward medical occurrence in a participant who received study drug 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 serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.
Recruitment status
COMPLETED
Target enrollment
1014 participants
Primary outcome timeframe
Baseline up to Day 832
Results posted on
2013-08-15
Participant Flow
Results for three unique protocols 0881A-101575 (NCT00195403), 0881A-102018 (NCT00195416), and 0881A-102212 (protocol not registered) were summarized in a single clinical study report.
Total of 1016 case report forms were retrieved, of these 2 were double registered. Out of 1014 participants, 16 were enrolled prior to the agreement date of the study and therefore excluded from the safety analysis population (998). Three participants had missing efficacy assessments (efficacy population = 995).
Participant milestones
| Measure |
Etanercept
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Overall Study
STARTED
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1014
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|
Overall Study
COMPLETED
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1014
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|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Baseline characteristics by cohort
| Measure |
Etanercept
n=998 Participants
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Age Continuous
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40.21 years
STANDARD_DEVIATION 15.13 • n=5 Participants
|
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Sex: Female, Male
Female
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465 Participants
n=5 Participants
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Sex: Female, Male
Male
|
533 Participants
n=5 Participants
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Primary diagnosis
Ankylosing Spondylitis
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520 participants
n=5 Participants
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|
Primary diagnosis
Rheumatoid Arthritis
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475 participants
n=5 Participants
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Primary diagnosis
Psoriatic Arthritis
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3 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to Day 832Population: Safety population included all participants who received \>= 1 dose of study medication and had the safety assessment through appropriate follow-up.
Any untoward medical occurrence in a participant who received study drug 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 serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.
Outcome measures
| Measure |
Etanercept
n=998 Participants
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Number of Participants With Adverse Events (AEs)
Any adverse event
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142 participants
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Number of Participants With Adverse Events (AEs)
Serious adverse event
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3 participants
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Number of Participants With Adverse Events (AEs)
Unexpected adverse event
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27 participants
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PRIMARY outcome
Timeframe: Baseline, Month 3Population: Efficacy population included all participants who received \>=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.
PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.
Outcome measures
| Measure |
Etanercept
n=995 Participants
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3
Baseline
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7.49 cm
Standard Deviation 1.30
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Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3
Change at Month 3
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-4.34 cm
Standard Deviation 1.86
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SECONDARY outcome
Timeframe: Baseline, Month 3, 9Population: Efficacy population included all participants who received \>=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.
Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Outcome measures
| Measure |
Etanercept
n=430 Participants
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9
Baseline
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17.42 joints
Standard Deviation 11.37
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Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9
Change at Month 3
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-12.67 joints
Standard Deviation 9.91
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Adverse Events
Etanercept
Serious events: 3 serious events
Other events: 142 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=998 participants at risk
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
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|
Infections and infestations
Herpes zoster
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
Other adverse events
| Measure |
Etanercept
n=998 participants at risk
Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
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|---|---|
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Skin and subcutaneous tissue disorders
Itching
|
3.6%
36/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
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Skin and subcutaneous tissue disorders
Rash
|
0.90%
9/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
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Skin and subcutaneous tissue disorders
Urticaria
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Macular rash
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Verruca vulgatis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
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Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
1.6%
16/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
15/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.60%
6/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site itching
|
1.2%
12/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site erythema
|
0.70%
7/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site reaction
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site edema
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site pain
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Cellulitis
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Injection site burning sensation
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Headache
|
0.70%
7/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Edema
|
0.60%
6/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Facial flushing
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Fever
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Chest pain
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Facial edema
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Asthenia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Chills
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Fatigue
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
5/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Anorexia
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.50%
5/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Hepatobiliary disorders
Increased Serum Glutamic Pyruvate Transaminase
|
0.40%
4/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Hepatobiliary disorders
Increased Serum Glutamic-oxaloacetic Transminase
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Infection
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Infection, aggravated
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Tuberculosis, bones and joints
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Abscess, pulmonary
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Ear discharge
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Infections and infestations
Shock, septic
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.30%
3/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Metabolism and nutrition disorders
Thirst
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Metabolism and nutrition disorders
Weight decrease
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Metabolism and nutrition disorders
Weight increase
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Auto-antibody response
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Eye disorders
Uveitis
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Eye disorders
Xerophthalmia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Nervous system disorders
Dizziness
|
0.20%
2/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Nervous system disorders
Paresthesia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Blood pressure high
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Blood and lymphatic system disorders
Lymph nodes enlarged
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
Renal and urinary disorders
Azotemia
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
|
General disorders
Palpitation
|
0.10%
1/998
All adverse events which occurred in the participants collected during the study period were included in reports regardless of their causal relationship with the study drug.
|
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