Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Certolizumab Pegol; Biological: Bimekizumab; Other: Placebo

• Registration Number: NCT02430909
• Lead Sponsor: UCB Celltech

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CZP / CZP + PBO / CZP	Certolizumab Pegol	Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 +Placebo from Week 8 to Week 18
CZP / CZP + UCB4940 / CZP	Certolizumab Pegol	Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 + UCB4940 from Week 8 until Week 18
CZP / CZP + PBO / CZP	Placebo	Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 +Placebo from Week 8 to Week 18
CZP / CZP + UCB4940 / CZP	Bimekizumab	Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30 + UCB4940 from Week 8 until Week 18
CZP / CZP/ CZP	Certolizumab Pegol	Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30

Primary Outcome Measures

Name	Time	Method
Change from Baseline 2 in DAS28(CRP)	Week 20	DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity.
Incidence of Adverse Events	Screening (D-28) until final study visit (Week 44)	All adverse events (AEs) are recorded during the entire study period.

Secondary Outcome Measures

Name	Time	Method
ACR50 response based on Baseline 2	Week 20	The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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).
Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2	Week 20	ACRn is the percentage improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and 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).
ACR20 response based on Baseline 2	Week 20	The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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).
ACR70 response based on Baseline 2	Week 20	The assessments are based on a 20% or greater improvement from Baseline 2 in the number of tender joints, 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).
DAS28(CRP) remission	Week 20	DAS28(CRP) remission is defined as DAS28(CRP) \< 2.6. DAS28 is a measure of disease activity in RA and is a composite score derived from the number of swollen and tender joints (out of 28) , the C-reactive protein value and the patient global assessment of disease activity.

Trial Locations

Locations (21)

Ra0123 203; 🇭🇺 Balatonfured, Hungary

Ra0123 801; 🇲🇩 Chisinau, Moldova, Republic of

Ra0123 303; 🇵🇱 Bialystok, Poland

Ra0123 306; 🇵🇱 Lublin, Poland

Ra0123 201; 🇭🇺 Budapest, Hungary

Ra0123 101; 🇨🇿 Praha 7, Czechia

Ra0123 204; 🇭🇺 Budapest, Hungary

Ra0123 202; 🇭🇺 Budapest, Hungary

Ra0123 304; 🇵🇱 Poznan, Poland

Ra0123 404; 🇷🇺 Moscow, Russian Federation

Ra0123 403; 🇷🇺 Moscow, Russian Federation

Ra0123 301; 🇵🇱 Warszawa, Poland

Ra0123 305; 🇵🇱 Poznan, Poland

Ra0123 405; 🇷🇺 Moscow, Russian Federation

Ra0123 406; 🇷🇺 Moscow, Russian Federation

Ra0123 407; 🇷🇺 Saint Petersburg, Russian Federation

Ra0123 408; 🇷🇺 Moscow, Russian Federation

Ra0123 402; 🇷🇺 Yaroslavl, Russian Federation

Ra0123 410; 🇷🇺 Yaroslavl, Russian Federation

Ra0123 501; 🇸🇰 Bratislava, Slovakia

Ra0123 601; 🇬🇧 Glasgow, United Kingdom