Trial record 1 of 1 for:
NCT02319642
An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044 (RAPID-C OLE)
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ClinicalTrials.gov Identifier: NCT02319642 |
Recruitment Status :
Completed
First Posted : December 18, 2014
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
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Sponsor:
UCB Pharma SA
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Rheumatoid Arthritis |
Intervention |
Drug: Certolizumab Pegol |
Enrollment | 347 |
Participant Flow
Recruitment Details | This study started to enroll subjects in November 2014 and concluded in December 2016. |
Pre-assignment Details | Participant Flow refers to the Safety Set consisting of all subjects who were dispensed medication. |
Arm/Group Title | Open-label Cimzia (Placebo in Feeder Study) | Open-label Cimzia (Cimzia in Feeder Study) |
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Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. | Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. |
Period Title: Overall Study | ||
Started | 95 | 251 |
Completed | 91 | 245 |
Not Completed | 4 | 6 |
Reason Not Completed | ||
Adverse Event | 2 | 4 |
Lack of Efficacy | 1 | 1 |
Withdrawal by Subject | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Open-label Cimzia (Placebo in Feeder Study) | Open-label Cimzia (Cimzia in Feeder Study) | Total Title | |
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Subjects were treated with Placebo in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects received either CZP 400 mg subcutaneously (sc) at Weeks 0, 2, and 4 followed by CZP 200 mg sc every two weeks (Q2W) if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. | Subjects were treated with CZP in the feeder study RA0044 (NCT02151851). In this OLE study, these subjects receive either CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W if they fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14 or CZP 200 mg sc Q2W if they completed RA0044 (NCT02151851) through week 24. | [Not Specified] | |
Overall Number of Baseline Participants | 95 | 251 | 346 | |
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Baseline Characteristics refer to the Safety Set. Demographic baseline refers to RA0044 (NCT02151851) baseline with a subset of subjects who enrolled into RA0078.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 95 participants | 251 participants | 346 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
91 95.8%
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239 95.2%
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330 95.4%
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>=65 years |
4 4.2%
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12 4.8%
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16 4.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 95 participants | 251 participants | 346 participants | |
46.3 (10.9) | 47.5 (11.6) | 47.2 (11.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 95 participants | 251 participants | 346 participants | |
Female |
77 81.1%
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216 86.1%
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293 84.7%
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Male |
18 18.9%
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35 13.9%
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53 15.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Responsible Party: | UCB Pharma ( UCB Pharma SA ) |
ClinicalTrials.gov Identifier: | NCT02319642 |
Other Study ID Numbers: |
RA0078 CTR20140412 ( Other Identifier: www.ChinaDrugTrials.org ) |
First Submitted: | December 15, 2014 |
First Posted: | December 18, 2014 |
Results First Submitted: | December 22, 2017 |
Results First Posted: | October 16, 2018 |
Last Update Posted: | October 16, 2018 |