A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT00160641
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Results First Posted: March 7, 2013
• Last Update Posted: March 27, 2020
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: Certolizumab Pegol	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 567 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050
• Study Start Date: November 2005
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Certolizumab Pegol; All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.	Biological: Certolizumab Pegol; Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.; Other Name: Cimzia

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years) ]
   An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
2. Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years) ]

   A SAE is any untoward medical occurrence that at any dose:

   • Results in death
   • Is life-threatening
   • Requires in patient hospitalisation or prolongation of existing hospitalisation
   • Results in persistent or significant disability/incapacity, or
   • Is a congenital anomaly or birth defect
   • Is as infection that requires treatment parenteral antibiotics
   • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

   First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

3. Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study [ Time Frame: From Entry Visit (Week 0) to the end of the study (approximately 6.3 years) ]

   An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.

   The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.

Secondary Outcome Measures :

1. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
   The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
2. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
   The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
3. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
   The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
4. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
   The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
5. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
   The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
6. Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
   The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
7. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
   The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
8. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
   The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
9. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
   The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
10. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
11. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
12. Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
13. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
14. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
15. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
16. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
17. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
18. Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 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). Baseline is Baseline of the preceding double-blind study.
19. Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS) [ Time Frame: From Baseline of the preceding double-blind study to Week 104 of the open-label study ]
    The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
20. Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
21. Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
22. Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.
23. Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.
24. Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).
25. Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Patients must have either failed to achieve an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the entire Week 24 assessment of C87050 [NCT00160602] trial.

Exclusion Criteria:

• A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
• A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
• Any concomitant biological therapy
• Any experimental therapy, within or outside a clinical

Contacts and Locations

Locations

United States, California

172

Palm Desert, California, United States

185

Pasadena, California, United States

170

Santa Maria, California, United States

194

Whittier, California, United States

United States, Florida

176

Naples, Florida, United States

186

Palm Harbor, Florida, United States

United States, Missouri

188

Kansas City, Missouri, United States

182

Saint Louis, Missouri, United States

United States, New Jersey

178

Stratford, New Jersey, United States

United States, Texas

192

Amarillo, Texas, United States

173

Austin, Texas, United States

175

San Antonio, Texas, United States

Bulgaria

303

Pleven, Bulgaria

302

Sofia, Bulgaria

Croatia

500

Rijeka, Croatia

Czechia

600

Brno, Czechia

603

Hlucin, Czechia

606

Praha 2, Czechia

605

Praha 5, Czechia

604

Sokolov, Czechia

602

Uherske Hradiste, Czechia

607

Zlin, Czechia

Estonia

700

Tallinn, Estonia

Israel

802

Afula, Israel

805

Ashkelon, Israel

807

Haifa, Israel

804

Jerusalem, Israel

801

Ramat Gan, Israel

806

Zerifin, Israel

Latvia

901

Daugavpils, Latvia

900

Riga, Latvia

Lithuania

103

Alytus, Lithuania

100

Kaunas, Lithuania

102

Klaipeda, Lithuania

101

Siauliai, Lithuania

Poland

124

Bialystok, Poland

120

Elblag, Poland

123

Krakow, Poland

125

Lublin, Poland

121

Sopot, Poland

122

Torun, Poland

Russian Federation

150

Moscow, Russian Federation

151

Moscow, Russian Federation

156

Moscow, Russian Federation

159

Moscow, Russian Federation

152

St. Petersburg, Russian Federation

154

St. Petersburg, Russian Federation

155

St. Petersburg, Russian Federation

158

St. Petersburg, Russian Federation

153

Yaroslavl, Russian Federation

Serbia

132

Belgrade, Serbia

133

Belgrade, Serbia

131

Niska Banja, Serbia

Slovakia

141

Kosice, Slovakia

143

Kosice, Slovakia

140

Piestany, Slovakia

142

Piestany, Slovakia

Ukraine

162

Dnepropetrovsk, Ukraine

161

Donetsk, Ukraine

168

Donetsk, Ukraine

165

Ivano-Frankivsk, Ukraine

163

Kiev, Ukraine

164

Kiev, Ukraine

167

Kiev, Ukraine

169

Kiev, Ukraine

160

Simferopol, Ukraine

166

Zaporozhye, Ukraine

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications:

Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00160641
• Other Study ID Numbers: C87051; 2005-002629-30 ( EudraCT Number )
• First Posted: September 12, 2005
• Results First Posted: March 7, 2013
• Last Update Posted: March 27, 2020
• Last Verified: March 2020

Keywords provided by UCB Pharma:

Rheumatoid Arthritis; CDP870; Certolizumab Pegol; Cimzia

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Certolizumab Pegol; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents