Clinical trial NCT00160641: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
CDP870
Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years
timeFrame: From first dose of CZP to the end of the open-label study (approximately 6.8 years)
measure: Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years
timeFrame: From first dose of CZP to the end of the open-label study (approximately 6.8 years)
measure: Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
timeFrame: From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)
Secondary outcomes:
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
timeFrame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100
timeFrame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148
timeFrame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196
timeFrame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244
timeFrame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
timeFrame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100
timeFrame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148
timeFrame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196
timeFrame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244
timeFrame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
timeFrame: From Baseline of the preceding double-blind study to Week 52 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100
timeFrame: From Baseline of the preceding double-blind study to Week 100 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148
timeFrame: From Baseline of the preceding double-blind study to Week 148 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196
timeFrame: From Baseline of the preceding double-blind study to Week 196 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244
timeFrame: From Baseline of the preceding double-blind study to Week 244 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)
timeFrame: From Baseline of the preceding double-blind study to Week 104 of the open-label study
measure: Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: 172
state: California
city: Pasadena
country: United States
facility: 185
state: California
city: Santa Maria
country: United States
facility: 170
state: California
city: Whittier
country: United States
facility: 194
state: California
city: Naples
country: United States
facility: 176
state: Florida
city: Palm Harbor
country: United States
facility: 186
state: Florida
city: Kansas City
country: United States
facility: 188
state: Missouri
city: Saint Louis
country: United States
facility: 182
state: Missouri
city: Stratford
country: United States
facility: 178
state: New Jersey
city: Amarillo
country: United States
facility: 192
state: Texas
city: Austin
country: United States
facility: 173
state: Texas
city: San Antonio
country: United States
facility: 175
state: Texas
city: Pleven
country: Bulgaria
facility: 303
city: Sofia
country: Bulgaria
facility: 302
city: Rijeka
country: Croatia
facility: 500
city: Brno
country: Czechia
facility: 600
city: Hlucin
country: Czechia
facility: 603
city: Praha 2
country: Czechia
facility: 606
city: Praha 5
country: Czechia
facility: 605
city: Sokolov
country: Czechia
facility: 604
city: Uherske Hradiste
country: Czechia
facility: 602
city: Zlin
country: Czechia
facility: 607
city: Tallinn
country: Estonia
facility: 700
city: Afula
country: Israel
facility: 802
city: Ashkelon
country: Israel
facility: 805
city: Haifa
country: Israel
facility: 807
city: Jerusalem
country: Israel
facility: 804
city: Ramat Gan
country: Israel
facility: 801
city: Zerifin
country: Israel
facility: 806
city: Daugavpils
country: Latvia
facility: 901
city: Riga
country: Latvia
facility: 900
city: Alytus
country: Lithuania
facility: 103
city: Kaunas
country: Lithuania
facility: 100
city: Klaipeda
country: Lithuania
facility: 102
city: Siauliai
country: Lithuania
facility: 101
city: Bialystok
country: Poland
facility: 124
city: Elblag
country: Poland
facility: 120
city: Krakow
country: Poland
facility: 123
city: Lublin
country: Poland
facility: 125
city: Sopot
country: Poland
facility: 121
city: Torun
country: Poland
facility: 122
city: Moscow
country: Russian Federation
facility: 150
city: Moscow
country: Russian Federation
facility: 151
city: Moscow
country: Russian Federation
facility: 156
city: Moscow
country: Russian Federation
facility: 159
city: St. Petersburg
country: Russian Federation
facility: 152
city: St. Petersburg
country: Russian Federation
facility: 154
city: St. Petersburg
country: Russian Federation
facility: 155
city: St. Petersburg
country: Russian Federation
facility: 158
city: Yaroslavl
country: Russian Federation
facility: 153
city: Belgrade
country: Serbia
facility: 132
city: Belgrade
country: Serbia
facility: 133
city: Niska Banja
country: Serbia
facility: 131
city: Kosice
country: Slovakia
facility: 141
city: Kosice
country: Slovakia
facility: 143
city: Piestany
country: Slovakia
facility: 140
city: Piestany
country: Slovakia
facility: 142
city: Dnepropetrovsk
country: Ukraine
facility: 162
city: Donetsk
country: Ukraine
facility: 161
city: Donetsk
country: Ukraine
facility: 168
city: Ivano-Frankivsk
country: Ukraine
facility: 165
city: Kiev
country: Ukraine
facility: 163
city: Kiev
country: Ukraine
facility: 164
city: Kiev
country: Ukraine
facility: 167
city: Kiev
country: Ukraine
facility: 169
city: Simferopol
country: Ukraine
facility: 160
city: Zaporozhye
country: Ukraine
facility: 166
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.