A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Infliximab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01313520

2011-000079-14 (EudraCT Number)

P08136

Details and patient eligibility

About

This is a study to compare the effect of infliximab versus placebo on synovial inflammation as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is that over 14 weeks of therapy, the change from baseline in the volume transfer rate in enhancing synovium is larger due to treatment with infliximab than with placebo.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have a clinical diagnosis of rheumatoid arthritis for at least 6 months
Must have at least 6 tender joints AND 6 swollen joints
Has a C-reactive protein ≥ 1.0 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
Baseline MRI must show evidence of synovitis in the wrist
Must have screening laboratory tests within acceptable levels
Women of childbearing potential and all men must agree to use a medically accepted method of contraception prior to entering the study and continue throughout study up to 6 weeks after study completion
Must meet tuberculosis (TB) screening criteria
Have received methotrexate therapy for ≥ 3 months; dose must be stable for at least 8 weeks
If taking the a disease modifying anti-rheumatic drug (DMARD) in combination with methotrexate must be on a stable dose
Must have a clinically acceptable 12 lead electrocardiogram (ECG)
If taking oral corticosteroids must be on a stable dose equivalent to ≤10 mg of prednisone (or prednisolone) per day for ≥2 weeks
If taking daily non-steroidal anti-inflammatory drug (NSAID) must be on a stable dose for ≥2 weeks; if taking NSAID on an as-needed basis must agree to discontinue use for at least 3 days and use only acetaminophen for breakthrough pain for 3 days before each MRI and clinic visit
If received biological therapies, the last dose of these drugs was to be received ≥ 3 months prior to the baseline visit AND the reason for discontinuations was not for safety considerations OR lack of efficacy

Exclusion criteria

Are pregnant, intend to become pregnant, or are breastfeeding
Has inflammatory arthritis other than RA
Has uncontrolled hypertension
Has moderate or severe congestive heart failure
Has a history of or current signs and/or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease
Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
Is currently participating in another clinical study or have participated in a clinical study (e.g., laboratory or clinical evaluation) within 4 weeks
Has history of any tumor with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
Has a history of any latent or active granulomatous infection including histoplasmosis, or coccidiomycosis
Had a non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months
Has a history of an infected joint prosthesis which has not been removed or replaced
Has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab
Has received rituximab or natalizumab
Has known claustrophobia or other contraindication to MRI
Does not meet washout period guidelines for previous treatments/injections/vaccinations