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Trial record 1 of 2 for:    NCT02151851
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A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis (RAPID-C)

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ClinicalTrials.gov Identifier: NCT02151851
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : March 20, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA, Belgium )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Certolizumab Pegol
Drug: Methotrexate
Other: Placebo
Enrollment 430
Recruitment Details The study started to enroll patients in July 2014 and concluded in June 2016.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo + Methotrexate Certolizumab Pegol + Methotrexate
Hide Arm/Group Description

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Period Title: Overall Study
Started 114 316
Included in the Safety Set 113 316
Completed 38 186
Not Completed 76 130
Reason Not Completed
Lack of Efficacy             67             94
Protocol Violation             0             1
Withdrawal by Subject             2             5
Medical impairment             1             0
Low compliance to study visits             0             1
Subject entered into study in error             0             1
Adverse Event             6             28
Arm/Group Title Placebo + Methotrexate Certolizumab Pegol + Methotrexate Total Title
Hide Arm/Group Description

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

[Not Specified]
Overall Number of Baseline Participants 113 316 429
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set which consisted of all subjects who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 316 participants 429 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
107
  94.7%
298
  94.3%
405
  94.4%
>=65 years
6
   5.3%
18
   5.7%
24
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 316 participants 429 participants
47.1  (11.1) 48.2  (11.8) 47.9  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 316 participants 429 participants
Female
95
  84.1%
268
  84.8%
363
  84.6%
Male
18
  15.9%
48
  15.2%
66
  15.4%
1.Primary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24
Hide Description The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.

NRI = non-responder imputation.

Arm/Group Title Placebo + Methotrexate (FAS) Certolizumab Pegol + Methotrexate (FAS)
Hide Arm/Group Description:

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Overall Number of Participants Analyzed 113 312
Measure Type: Number
Unit of Measure: percentage of participants
23.9 54.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (FAS), Certolizumab Pegol + Methotrexate (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.899
Confidence Interval (2-Sided) 95%
2.382 to 6.382
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24
Hide Description The assessments are based on a 50 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.

NRI = non-responder imputation.

Arm/Group Title Placebo + Methotrexate (FAS) Certolizumab Pegol + Methotrexate (FAS)
Hide Arm/Group Description:

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Overall Number of Participants Analyzed 113 312
Measure Type: Number
Unit of Measure: percentage of participants
7.1 36.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (FAS), Certolizumab Pegol + Methotrexate (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.641
Confidence Interval (2-Sided) 95%
3.570 to 16.352
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 24
Hide Description The assessments are based on a 70 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.

NRI = non-responder imputation.

Arm/Group Title Placebo + Methotrexate (FAS) Certolizumab Pegol + Methotrexate (FAS)
Hide Arm/Group Description:

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Overall Number of Participants Analyzed 113 312
Measure Type: Number
Unit of Measure: percentage of participants
2.7 16.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Methotrexate (FAS), Certolizumab Pegol + Methotrexate (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.248
Confidence Interval (2-Sided) 95%
2.209 to 23.786
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
Hide Description The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3. A total score is computed from the item scores using the scoring rules provided by the index's author. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.

LOCF = last observation carried forward. Only subjects with available HAQ-DI scores at week 24 were included.

Arm/Group Title Placebo + Methotrexate (FAS) Certolizumab Pegol + Methotrexate (FAS)
Hide Arm/Group Description:

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Overall Number of Participants Analyzed 110 306
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.185  (0.463) -0.530  (0.589)
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) up to Week 25.
Adverse Event Reporting Description Adverse Events refer to the Safety Set which consists of all subjects who received at least 1 dose of study medication.
 
Arm/Group Title Placebo + Methotrexate (SS) Certolizumab Pegol + Methotrexate (SS)
Hide Arm/Group Description

Subjects will receive Placebo (1mL / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

All-Cause Mortality
Placebo + Methotrexate (SS) Certolizumab Pegol + Methotrexate (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo + Methotrexate (SS) Certolizumab Pegol + Methotrexate (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/113 (2.65%)      20/316 (6.33%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Cardiac disorders     
Aortic valve incompetence * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Cardiac arrest * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Gastrointestinal disorders     
Gastric ulcer * 1  0/113 (0.00%)  0 2/316 (0.63%)  2
Gastritis * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Ascites * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Hepatobiliary disorders     
Cholecystitis chronic * 1  1/113 (0.88%)  1 0/316 (0.00%)  0
Cholelithiasis * 1  1/113 (0.88%)  1 0/316 (0.00%)  0
Liver injury * 1  0/113 (0.00%)  0 2/316 (0.63%)  2
Bile duct stone * 1  1/113 (0.88%)  1 0/316 (0.00%)  0
Immune system disorders     
Anaphylactic shock * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Infections and infestations     
Pneumonia * 1  0/113 (0.00%)  0 2/316 (0.63%)  2
Pulmonary tuberculosis * 1  0/113 (0.00%)  0 2/316 (0.63%)  2
Pericarditis tuberculous * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Tuberculous pleurisy * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Injury, poisoning and procedural complications     
Multiple fractures * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Spinal compression fracture * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Investigations     
Protein urine present * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Osteonecrosis * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Sjogren's syndrome * 1  1/113 (0.88%)  1 0/316 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung adenocarcinoma * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Nervous system disorders     
Subarachnoid haemorrhage * 1  1/113 (0.88%)  1 0/316 (0.00%)  0
Renal and urinary disorders     
Haematuria * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Pleural effusion * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Respiratory failure * 1  0/113 (0.00%)  0 1/316 (0.32%)  1
Pulmonary mass * 1  0/113 (0.00%)  0 2/316 (0.63%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Methotrexate (SS) Certolizumab Pegol + Methotrexate (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/113 (42.48%)      130/316 (41.14%)    
Blood and lymphatic system disorders     
Anaemia * 1  7/113 (6.19%)  9 17/316 (5.38%)  19
Infections and infestations     
Upper respiratory tract infection * 1  15/113 (13.27%)  21 50/316 (15.82%)  60
Latent tuberculosis * 1  7/113 (6.19%)  7 24/316 (7.59%)  24
Urinary tract infection * 1  7/113 (6.19%)  11 13/316 (4.11%)  18
Investigations     
Liver function test abnormal * 1  4/113 (3.54%)  6 22/316 (6.96%)  24
Alanine aminotransferase increased * 1  8/113 (7.08%)  9 19/316 (6.01%)  26
White blood cell count decreased * 1  1/113 (0.88%)  1 18/316 (5.70%)  24
Aspartate aminotransferase increased * 1  7/113 (6.19%)  8 16/316 (5.06%)  18
Neutrophil count increased * 1  8/113 (7.08%)  12 6/316 (1.90%)  6
Lymphocyte count decreased * 1  8/113 (7.08%)  11 2/316 (0.63%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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, Belgium )
ClinicalTrials.gov Identifier: NCT02151851    
Other Study ID Numbers: RA0044
First Submitted: May 28, 2014
First Posted: May 30, 2014
Results First Submitted: June 7, 2017
Results First Posted: March 20, 2018
Last Update Posted: June 28, 2018