Trial Outcomes & Findings for Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis (NCT NCT00245960)

Last Updated: 2022-01-31

Results Overview

The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

752 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-01-31

Participant Flow

Subjects were recruited worldwide from December 2005 to September 2007.

Subjects were screened up to 4 weeks.

Participant milestones

Participant milestones
Measure	Etanercept BIW/QW Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
Period 1 (Double Blind): 1-12 Weeks STARTED	379	373
Period 1 (Double Blind): 1-12 Weeks COMPLETED	364	362
Period 1 (Double Blind): 1-12 Weeks NOT COMPLETED	15	11
Period 2 (Open Label): 13-24 Weeks STARTED	364	362
Period 2 (Open Label): 13-24 Weeks COMPLETED	350	344
Period 2 (Open Label): 13-24 Weeks NOT COMPLETED	14	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept BIW/QW Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
Period 1 (Double Blind): 1-12 Weeks Adverse Event	6	7
Period 1 (Double Blind): 1-12 Weeks Pregnancy	0	1
Period 1 (Double Blind): 1-12 Weeks Withdrawal of consent	2	0
Period 1 (Double Blind): 1-12 Weeks Unsatisfactory Response	2	1
Period 1 (Double Blind): 1-12 Weeks Protocol Violation	3	0
Period 1 (Double Blind): 1-12 Weeks Withdrawal by Subject	2	2
Period 2 (Open Label): 13-24 Weeks Adverse Event	8	4
Period 2 (Open Label): 13-24 Weeks Lost to Follow-up	2	2
Period 2 (Open Label): 13-24 Weeks Unsatisfactory Response	2	5
Period 2 (Open Label): 13-24 Weeks Withdrawal by Subject	1	3
Period 2 (Open Label): 13-24 Weeks Protocol Violation	1	3
Period 2 (Open Label): 13-24 Weeks Withdrawal of consent	0	1

Baseline Characteristics

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept BIW/QW n=379 Participants Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW n=373 Participants Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Total n=752 Participants Total of all reporting groups
Age, Continuous	46.11 years STANDARD_DEVIATION 11.39 • n=99 Participants	46.93 years STANDARD_DEVIATION 11.41 • n=107 Participants	46.52 years STANDARD_DEVIATION 11.40 • n=206 Participants
Sex: Female, Male Female	136 Participants n=99 Participants	143 Participants n=107 Participants	279 Participants n=206 Participants
Sex: Female, Male Male	243 Participants n=99 Participants	230 Participants n=107 Participants	473 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.

The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.

Outcome measures

Outcome measures
Measure	Etanercept BIW/QW n=379 Participants Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW n=373 Participants Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis	176 participants	119 participants

SECONDARY outcome

Timeframe: 12 and 24 weeks

The PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Outcome measures

Outcome measures
Measure	Etanercept BIW/QW n=372 Participants Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW n=372 Participants Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) At 12 Weeks	284 participants	282 participants
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) At 24 Weeks	303 participants	299 participants

Adverse Events

Etanercept BIW/QW

Serious events: 15 serious events

Other events: 213 other events

Deaths: 0 deaths

Etanercept QW/QW

Serious events: 11 serious events

Other events: 190 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Etanercept BIW/QW Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
General disorders Headache	5.0% 19/379 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.	5.1% 19/373 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	8.4% 32/379 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.	6.2% 23/373 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.
Cardiac disorders Cardiovascular general disorders	6.3% 24/379 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.	6.2% 23/373 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 Digestive general disorders	10.0% 38/379 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.	9.9% 37/373 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 Metabolic and nutritional general disorders	6.1% 23/379 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.	5.4% 20/373 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.
Nervous system disorders Nervous general disorders	6.3% 24/379 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.	4.8% 18/373 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.
Respiratory, thoracic and mediastinal disorders Pharyngitis	5.8% 22/379 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.	6.4% 24/373 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	13.2% 50/379 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.	9.7% 36/373 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 Skin and appendages general disorders	11.9% 45/379 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.	11.0% 41/373 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: [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

Measure	Etanercept BIW/QW Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.	Etanercept QW/QW Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
General disorders Abdominal pain	0.26% 1/379 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% 0/373 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 Abscess	0.00% 0/379 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.	0.27% 1/373 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 Accidental injury	0.26% 1/379 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.	0.27% 1/373 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 Fever	0.26% 1/379 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% 0/373 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 Infection	0.26% 1/379 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.	0.54% 2/373 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.
Vascular disorders Cerebral ischemia	0.26% 1/379 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.	0.27% 1/373 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.
Vascular disorders Cerebrovascular accident	0.26% 1/379 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.	0.27% 1/373 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.
Cardiac disorders Myocardial ischemia	0.26% 1/379 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% 0/373 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 Gastrointestinal hemorrhage	0.00% 0/379 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.	0.27% 1/373 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 Large intestine perforation	0.26% 1/379 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% 0/373 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 Melena	0.00% 0/379 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.	0.27% 1/373 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	0.26% 1/379 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% 0/373 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 Stomach ulcer hemorrhage	0.00% 0/379 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.	0.27% 1/373 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 Vomiting	0.26% 1/379 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.	0.27% 1/373 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.
Blood and lymphatic system disorders Anemia	0.26% 1/379 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% 0/373 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.
Nervous system disorders Abnormal gait	0.26% 1/379 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% 0/373 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.
Nervous system disorders Depression	0.26% 1/379 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% 0/373 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.
Nervous system disorders Dizziness	0.26% 1/379 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% 0/373 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.
Nervous system disorders Paresthesia	0.26% 1/379 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% 0/373 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease	0.26% 1/379 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% 0/373 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 Psoriasis	0.53% 2/379 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.	0.27% 1/373 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 Skin carcinoma	0.53% 2/379 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.	0.27% 1/373 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast carcinoma	0.26% 1/379 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% 0/373 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.
Renal and urinary disorders Kidney pain	0.00% 0/379 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.	0.27% 1/373 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 Local reaction to procedure	0.26% 1/379 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% 0/373 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.