Trial Outcomes & Findings for A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA) (NCT NCT01292265)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

From Baseline (Week 0) to Week 12

Results posted on

2018-08-01

Participant Flow

This study started in February 2011. It was subsequently terminated due to low enrollment. Baseline characteristics refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once. There was a total of 3 subjects enrolled in this study.

Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Participant milestones

Participant milestones
Measure	CZP 200 mg Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CZP 200 mg n=3 Participants Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Week 0) to Week 12

Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 12

Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 12

Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline (Week 0) to Week 12

Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.

Outcome measures

Outcome data not reported

Adverse Events

CZP 200 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CZP 200 mg n=3 participants at risk Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Infections and infestations Nasopharyngitis	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.
Investigations Transaminases increased	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.
Investigations Blood creatine phosphokinase increased	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.
Skin and subcutaneous tissue disorders Urticaria	33.3% 1/3 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages. Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once.

Additional Information

Study Director

UCB, Inc.

Phone: +1 887 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER