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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430909
• Other study ID #: RA0123
• Secondary ID: 2014-003307-30
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2015
• Last updated: May 29, 2017
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• 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

Locations

Country	Name	City	State
Czechia	Ra0123 101	Praha 7
Hungary	Ra0123 203	Balatonfured
Hungary	Ra0123 201	Budapest
Hungary	Ra0123 202	Budapest
Hungary	Ra0123 204	Budapest
Moldova, Republic of	Ra0123 801	Chisinau
Poland	Ra0123 303	Bialystok
Poland	Ra0123 306	Lublin
Poland	Ra0123 304	Poznan
Poland	Ra0123 305	Poznan
Poland	Ra0123 301	Warszawa
Russian Federation	Ra0123 403	Moscow
Russian Federation	Ra0123 404	Moscow
Russian Federation	Ra0123 405	Moscow
Russian Federation	Ra0123 406	Moscow
Russian Federation	Ra0123 408	Moscow
Russian Federation	Ra0123 407	Saint Petersburg
Russian Federation	Ra0123 402	Yaroslavl
Russian Federation	Ra0123 410	Yaroslavl
Slovakia	Ra0123 501	Bratislava
United Kingdom	Ra0123 601	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
UCB Celltech	PRA Health Sciences

Countries where clinical trial is conducted

Czechia,  Hungary,  Moldova, Republic of,  Poland,  Russian Federation,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	All adverse events (AEs) are recorded during the entire study period.	Screening (D-28) until final study visit (Week 44)
Primary	Change from Baseline 2 in DAS28(CRP)	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.	Week 20
Secondary	Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2	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).	Week 20
Secondary	ACR20 response based on Baseline 2	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).	Week 20
Secondary	ACR50 response based on Baseline 2	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).	Week 20
Secondary	ACR70 response based on Baseline 2	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).	Week 20
Secondary	DAS28(CRP) remission	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.	Week 20