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

Sponsor

UCB Celltech (Industry)

Overall Status

Completed

CT.gov ID

NCT02430909

Collaborator

PRA Health Sciences (Industry)

159

Enrollment

Locations

Arms

Actual Duration (Months)

7.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: Bimekizumab Biological: Certolizumab Pegol Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: CZP / CZP + PBO / CZP 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	Biological: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection Other: Placebo Pharmaceutical form: Solution for infusion Concentration: 0.9% saline Route of administration: Intravenous infusion
Experimental: CZP / CZP + UCB4940 / CZP 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	Biological: Bimekizumab Pharmaceutical form: Solution for infusion Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose Route of administration: iv infustion Biological: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection
Other: CZP / CZP/ CZP Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30	Biological: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection

Arm

Intervention/Treatment

Placebo Comparator: CZP / CZP + PBO / CZP

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

Biological: Certolizumab Pegol

Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection

Other: Placebo

Pharmaceutical form: Solution for infusion Concentration: 0.9% saline Route of administration: Intravenous infusion

Experimental: CZP / CZP + UCB4940 / CZP

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

Biological: Bimekizumab

Pharmaceutical form: Solution for infusion Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose Route of administration: iv infustion

Biological: Certolizumab Pegol

Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection

Other: CZP / CZP/ CZP

Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30

Biological: Certolizumab Pegol

Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ml Route of administration: Subcutaneous injection

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events [Screening (D-28) until final study visit (Week 44)]
All adverse events (AEs) are recorded during the entire study period.
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.

Secondary Outcome Measures

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).
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met:

Subject is informed and given approved written Informed Consent Form (ICF).
Subject is considered reliable and capable of adhering to the protocol.
Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months' duration as defined by ACR/EULAR 2010 classification criteria.
Subject must have:
≥6 tender joints (out of 68)
≥6 swollen joints (out of 66)
CRP≥10.0mg/L .
Subject must have had inadequate response to at least 1 synthetic DMARD.
Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening).
Female subjects must either be:
postmenopausal
permanently sterilized or,
if of childbearing potential, must be willing to use at least 2 effective methods of contraception,
Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.

Exclusion Criteria

Subjects are not permitted to enroll in the study if any of the following criteria is met:

Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP).
Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens.
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded.
Subject is at high risk of infection.
Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0.
Subject has renal or liver impairment.
Subject has a current or past history of gastrointestinal ulceration.
Subject has active neoplastic disease or history of neoplastic disease.
Subject has a concomitant diagnosis of any other inflammatory condition.
Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.

Contacts and Locations

Locations

	Site	City	Country
1	Ra0123 101	Praha 7	Czechia
2	Ra0123 203	Balatonfured	Hungary
3	Ra0123 201	Budapest	Hungary
4	Ra0123 202	Budapest	Hungary
5	Ra0123 204	Budapest	Hungary
6	Ra0123 801	Chisinau	Moldova, Republic of
7	Ra0123 303	Bialystok	Poland
8	Ra0123 306	Lublin	Poland
9	Ra0123 304	Poznan	Poland
10	Ra0123 305	Poznan	Poland
11	Ra0123 301	Warszawa	Poland
12	Ra0123 403	Moscow	Russian Federation
13	Ra0123 404	Moscow	Russian Federation
14	Ra0123 405	Moscow	Russian Federation
15	Ra0123 406	Moscow	Russian Federation
16	Ra0123 408	Moscow	Russian Federation
17	Ra0123 407	Saint Petersburg	Russian Federation
18	Ra0123 402	Yaroslavl	Russian Federation
19	Ra0123 410	Yaroslavl	Russian Federation
20	Ra0123 501	Bratislava	Slovakia
21	Ra0123 601	Glasgow	United Kingdom

Sponsors and Collaborators

UCB Celltech
PRA Health Sciences

Investigators

Study Director: UCB Cares, +1 844 599 2273 (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UCB Celltech

ClinicalTrials.gov Identifier:

NCT02430909

Other Study ID Numbers:

RA0123
2014-003307-30

First Posted:

Apr 30, 2015

Last Update Posted:

May 31, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Certolizumab Pegol

Study Results

No Results Posted as of May 31, 2017