Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003307-30-SK
• Lead Sponsor: CB Celltech, UK Registered Branch of UCB Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Study Completion: 2017-04-19
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified