Trial Outcomes & Findings for Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA) (NCT NCT04428502)
NCT ID: NCT04428502
Last Updated: 2021-09-14
Results Overview
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
COMPLETED
127 participants
Baseline, Month 1
2021-09-14
Participant Flow
Data of Iraq's participants, 1) who aged greater than or equal to (\>=) 18 years, 2) who met American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for psoriatic arthritis (PsA), and 3) who received etanercept for at least for 1 year from May 2012 until August 2019 in the Baghdad teaching hospital (rheumatology center) were collected. Data collected were assessed in approximately 1.8 months of this retrospective observational study.
Participant milestones
| Measure |
Etanercept
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
|
|---|---|
|
Overall Study
STARTED
|
127
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Etanercept
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
|
|---|---|
|
Overall Study
Did not meet entrance criteria
|
14
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept
n=127 Participants
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.
|
|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 12.4 • n=127 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1Population: Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 1, 6 and 12Population: Analysis was performed on all participants who were included in this study.
DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (\<=) 3.2 = low disease activity, DAS28 ESR greater than (\>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Outcome measures
| Measure |
Etanercept: ACCP Positive
n=20 Participants
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.
|
Etanercept: ACCP Negative
n=107 Participants
Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.
|
|---|---|---|
|
Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
Month 1
|
4.2 units on a scale
Standard Deviation 0.77
|
4.1 units on a scale
Standard Deviation 0.8
|
|
Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
Month 6
|
4.06 units on a scale
Standard Deviation 0.93
|
3.35 units on a scale
Standard Deviation 1.08
|
|
Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
Month 12
|
3.34 units on a scale
Standard Deviation 1.1
|
2.66 units on a scale
Standard Deviation 0.91
|
Adverse Events
Etanercept
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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