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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01313520
Date of registration: 25/02/2011
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: 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)
Scientific title: A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)
Date of first enrolment: March 1, 2011
Target sample size: 61
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01313520
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Moldova, Republic of Romania
Contacts
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Drug: Infliximab
Drug: Placebo
Primary Outcome(s)
Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans) [Time Frame: Baseline and week 14]
Secondary Outcome(s)
Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans. [Time Frame: Baseline and Week 14]
Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis. [Time Frame: Baseline and Week 14]
Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20). [Time Frame: Baseline and week 14]
Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50). [Time Frame: Baseline and week 14]
Secondary ID(s)
2011-000079-14
P08136
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 08/07/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01313520
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