Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA) (MARVELOUS)

UCB

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab Pegol (CZP) 400 mg; Biological: Certolizumab Pegol (CZP) 200 mg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235598

2009-013758-33 (EudraCT Number)

RA0028

Details and patient eligibility

About

Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.

Full description

To identify the efficacy of Certolizumab Pegol (CZP) on synovitis in dynamic MRI parameters; to make the correlation between European League Against Rheumatism (EULAR), American College of Rheumatology (ACR)p, Disease Activity Score-28 (DAS 28) responses, and Digital XRay (DXR) assessment with reduction of synovitis.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a diagnosis of adult-onset Rheumatoid Arthritis (RA) of at least 3 months duration but no longer than 15 years
• Subjects with an active adult Rheumatoid Arthritis disease
• Subjects who have been on Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy for at least 12 weeks

Exclusion criteria

• Subject must not have a secondary, non-inflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
• Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
• Subject must not have a history of an infected joint prosthesis at any time with prosthesis still in situ
• Subject must not have received more than 1 biological agent
• Subject must not have a history of lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
• Subject with known Tuberculosis (TB) disease, high risk of acquiring TB infection or latent TB infection
• Subject must not have a known hypersensitivity to any components of the investigational medicinal product
• Subject must not have contraindications for Magnetic Resonance Image (MRI) and contrast agent
• Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

41 participants in 2 patient groups

Placebo followed by Certolizumab Pegol (CZP)

Other group

Description:

Placebo, saline solution for sc injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40

Treatment:

Other: Placebo

Biological: Certolizumab Pegol (CZP) 200 mg

Biological: Certolizumab Pegol (CZP) 400 mg

Certolizumab Pegol (CZP)

Experimental group

Description:

Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40

Treatment:

Biological: Certolizumab Pegol (CZP) 200 mg

Biological: Certolizumab Pegol (CZP) 400 mg