Clinical trial NCT00843778: Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Official title: A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Moderate to Low Disease Activity
Certolizumab Pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 131
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: To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Detailed description: This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 \[NCT00674362\] designed to continue to assess the safety and efficacy of Certolizumab Pegol.

Two different population will enter the study from C87076 \[NCT00674362\] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB:

Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 \[NCT00674362\].The Week 24 assessment (visit 14) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 \[NCT00674362\].

Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 \[NCT00674362\]. The Week 52 assessment (visit 26) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080.

Subjects who flared prior to Week 48 in the C87076 \[NCT00674362\] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study.

Those who flared at Week 48 or Week 52, will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
* either failed to achieve remission after 6 months of study treatment
* or flared after the 6 months of study treatment and completed the study (C87076 \[NCT00674362\])

Exclusion Criteria:

* All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Primary outcomes:
measure: Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
timeFrame: From Entry Visit up to approximately 144 weeks
measure: Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period
timeFrame: From Entry Visit up to approximately 144 weeks
Secondary outcomes:
measure: Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit
timeFrame: Completion/Withdrawal Visit (up to approximately Week 136)
measure: Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit
timeFrame: Completion/Withdrawal Visit (up to approximately Week 136)
measure: Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit
timeFrame: Completion/Withdrawal Visit (up to approximately Week 136)
measure: Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)
measure: Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit
timeFrame: Week 24
measure: Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study
timeFrame: Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)
measure: Percentage of Subjects Willing to Self-inject at Week 0
timeFrame: Week 0 of this study (C87080 [NCT00843778])
measure: Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
timeFrame: Week 0 of this study (C87080 [NCT00843778])
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0
timeFrame: Week 0 of this study (C87080 [NCT00843778])
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2
timeFrame: Week 2
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4
timeFrame: Week 4
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6
timeFrame: Week 6
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8
timeFrame: Week 8
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10
timeFrame: Week 10
measure: Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
timeFrame: Week 12
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0
timeFrame: Week 0
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2
timeFrame: Week 2
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4
timeFrame: Week 4
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6
timeFrame: Week 6
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8
timeFrame: Week 8
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10
timeFrame: Week 10
measure: Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Wien
country: Austria
facility: 6
city: Rennes
country: France
facility: 11
city: Toulouse
country: France
facility: 64
city: Tours
country: France
facility: 10
city: Berlin
country: Germany
facility: 17
city: Berlin
country: Germany
facility: 47
city: Erlangen
country: Germany
facility: 20
city: Essen
country: Germany
facility: 50
city: Frankfurt
country: Germany
facility: 16
city: Heidelberg
country: Germany
facility: 19
city: Herne
country: Germany
facility: 15
city: Ratingen
country: Germany
facility: 24
city: Vogelsang-Gommern
country: Germany
facility: 18
city: Wuerzburg
country: Germany
facility: 23
city: Pavia
country: Italy
facility: 29
city: Roma
country: Italy
facility: 34
city: Bydgoszcz
country: Poland
facility: 58
city: Elblag
country: Poland
facility: 67
city: Lublin
country: Poland
facility: 62
city: Poznan
country: Poland
facility: 55
city: Poznan
country: Poland
facility: 65
city: Sopot
country: Poland
facility: 60
city: Szczecin
country: Poland
facility: 57
city: Torun
country: Poland
facility: 69
city: Warszawa
country: Poland
facility: 53
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: