Trial Outcomes & Findings for Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients (NCT NCT01288287)

NCT ID: NCT01288287

Last Updated: 2016-09-16

Results Overview

DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using: DAS28(ESR) = 0.56 \* √(TJC) + 0.28\* √(SJC) + 0.70\* ln(ESR) + 0.014\* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors. DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.

• Recruitment status: COMPLETED
• Target enrollment: 149 participants
• Primary outcome timeframe: Baseline (Week 0), 78 weeks
• Results posted on: 2016-09-16

Participant Flow

This observational study started to enroll patients in July 2011 in the United Kingdom and Ireland.

Of the 149 enrolled patients, 147 are included in the Safety Set.

Participant milestones

Measure	All Patients Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
Overall Study STARTED	149
Overall Study Safety Set	147
Overall Study Full Analysis Set	111
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Measure	All Patients Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	4
Overall Study Lack of Efficacy	13
Overall Study Other Reason	13
Overall Study Unknown Reason	1
Overall Study Unknown Status	7

Baseline Characteristics

Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients

Baseline characteristics by cohort

Measure	Safety Set (All Patients) n=147 Participants Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Age, Continuous	55.6 years STANDARD_DEVIATION 11.85 • n=5 Participants
Age, Customized < 65 years	111 participants n=5 Participants
Age, Customized >= 65 years	36 participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), 78 weeks

Population: Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).

DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:

DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.

DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.

Outcome measures

Measure	Week 12 Disease Activity Score (DAS) Responders n=44 Participants Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12	Week 12 Disease Activity Score (DAS) Non-Responders n=14 Participants Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points	79.5 percentage of patients Interval 64.7 to 90.2	50.0 percentage of patients Interval 23.0 to 77.0

SECONDARY outcome

Timeframe: Baseline (Week 0), 78 weeks

Population: Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).

DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:

DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.

DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity.

Outcome measures

Measure	Week 12 Disease Activity Score (DAS) Responders n=44 Participants Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12	Week 12 Disease Activity Score (DAS) Non-Responders n=14 Participants Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks	-2.45 units on a scale Standard Deviation 1.454	-1.63 units on a scale Standard Deviation 1.157

SECONDARY outcome

Timeframe: Baseline (Week 0), 78 weeks

Population: Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).

Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:

• DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,
• DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,
• DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders.

Outcome measures

Measure	Week 12 Disease Activity Score (DAS) Responders n=44 Participants Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12	Week 12 Disease Activity Score (DAS) Non-Responders n=14 Participants Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline Good Response	47.7 percentage of patients	35.7 percentage of patients
Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline Moderate Response	36.4 percentage of patients	50.0 percentage of patients
Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline No Response	15.9 percentage of patients	14.3 percentage of patients

SECONDARY outcome

Timeframe: Baseline (Week 0), 78 weeks

Population: Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).

RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.

A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks.

Outcome measures

Measure	Week 12 Disease Activity Score (DAS) Responders n=51 Participants Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12	Week 12 Disease Activity Score (DAS) Non-Responders n=17 Participants Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks	-2.64 units on a scale Standard Deviation 2.262	-1.78 units on a scale Standard Deviation 3.048

SECONDARY outcome

Timeframe: Baseline (Week 0), 78 weeks

Population: Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).

HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.

Outcome measures

Measure	Week 12 Disease Activity Score (DAS) Responders n=50 Participants Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12	Week 12 Disease Activity Score (DAS) Non-Responders n=17 Participants Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks	-0.43 units on a scale Standard Deviation 0.506	-0.34 units on a scale Standard Deviation 0.606

Adverse Events

Safety Set (All Patients)

Serious events: 8 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Safety Set (All Patients) n=147 participants at risk Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Infections and infestations Cellulitis	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Infections and infestations Pulmonary Tuberculosis	1.4% 2/147 • Number of events 2 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Surgical and medical procedures Abortion induced	1.4% 2/147 • Number of events 2 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Investigations Liver function test abnormal	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.

Other adverse events

Measure	Safety Set (All Patients) n=147 participants at risk Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic. Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Injury, poisoning and procedural complications Exposure during pregnancy	1.4% 2/147 • Number of events 2 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.
Respiratory, thoracic and mediastinal disorders Cough	0.68% 1/147 • Number of events 1 • Treatment emergent adverse drug reactions (TEADRs) were collected up to 88 weeks. TEADRs are events with an onset date from the first dose of Certolizumab Pegol (CZP) to 10 weeks after the last dose of CZP. Adverse Drug Reactions presented below refer to the Safety Set, consisting of all patients entered into the study who took at least one dose of Certolizumab Pegol.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60