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Trial record 1 of 1 for:    NCT02319642
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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
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
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
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)
Hide Arm/Group Description 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
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study) Total Title
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set. Demographic baseline refers to RA0044 (NCT02151851) baseline with a subset of subjects who enrolled into RA0078.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 251 participants 346 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
  95.8%
239
  95.2%
330
  95.4%
>=65 years
4
   4.2%
12
   4.8%
16
   4.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 95 participants 251 participants 346 participants
Female
77
  81.1%
216
  86.1%
293
  84.7%
Male
18
  18.9%
35
  13.9%
53
  15.3%
1.Primary Outcome
Title Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)
Hide Description TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Time Frame Baseline to the end of observation period (32 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
2.1 1.6
2.Primary Outcome
Title Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
Hide Description TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.
Time Frame Baseline to the end of observation period (32 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
65.3 65.3
3.Primary Outcome
Title Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)
Hide Description Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.
Time Frame Baseline to the end of observation period (32 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
6.3 2.0
4.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline
Hide Description

The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set with Non-Responder-Imputation (NRI).
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
72.6 82.1
5.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline
Hide Description

The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set with Non-Responder-Imputation (NRI).
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
45.3 56.6
6.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline
Hide Description

The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).

Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set with Non-Responder-Imputation (NRI).
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Measure Type: Number
Unit of Measure: percentage of participants
17.9 31.5
7.Secondary Outcome
Title Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description

Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability.

Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set with last observation carried forward (LOCF). Only subjects with available data are included in the analysis of this Outcome Measure.
Arm/Group Title Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Hide Arm/Group Description:
Subjects were treated with Placebo in 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 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.
Overall Number of Participants Analyzed 95 251
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.526  (0.621) -0.681  (0.611)
Time Frame Adverse events were collected from Baseline of RA0078 until Safety Follow Up visit (up to Week 32).
Adverse Event Reporting Description Adverse Events refer to the Safety Population 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)
Hide Arm/Group Description 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.
All-Cause Mortality
Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/95 (0.00%)      0/251 (0.00%)    
Hide Serious Adverse Events
Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/95 (6.32%)      5/251 (1.99%)    
Gastrointestinal disorders     
Pancreatitis acute * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Duodenal ulcer haemorrhage * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Mouth ulceration * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Cholelithiasis * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Infections and infestations     
Appendiceal abscess * 1  0/95 (0.00%)  0 1/251 (0.40%)  1
Herpes zoster * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Tuberculosis * 1  0/95 (0.00%)  0 1/251 (0.40%)  1
Injury, poisoning and procedural complications     
Spinal compression fracture * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
Clavicle fracture * 1  0/95 (0.00%)  0 1/251 (0.40%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  0/95 (0.00%)  0 1/251 (0.40%)  1
Rheumatoid arthritis * 1  0/95 (0.00%)  0 1/251 (0.40%)  1
Surgical and medical procedures     
Hospitalisation * 1  1/95 (1.05%)  1 0/251 (0.00%)  0
1
Term from vocabulary, MedDRA15.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label Cimzia (Placebo in Feeder Study) Open-label Cimzia (Cimzia in Feeder Study)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/95 (22.11%)      55/251 (21.91%)    
Blood and lymphatic system disorders     
Anaemia * 1  5/95 (5.26%)  7 14/251 (5.58%)  15
Infections and infestations     
Upper respiratory tract infection * 1  13/95 (13.68%)  14 39/251 (15.54%)  45
Investigations     
Liver function test abnormal * 1  5/95 (5.26%)  8 11/251 (4.38%)  11
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
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