An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00941707
• Date of registration: 16/07/2009
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis
• Scientific title: A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy
• Date of first enrolment: February 2010
• Target sample size: 86
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00941707
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Czech Republic, Ireland, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987
criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening

- Participants who have been treated with and tolerated methotrexate (MTX) treatment at
dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months
before Screening

- Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other
analgesics (drug used to control pain) regularly for RA, participants must have been
on a stable dose for at least 2 weeks before the first dose of study medication

- Participants if using oral corticosteroids (compounds, usually hormonal, taken orally
[by mouth] in order to block ovulation [discharge of an egg from the ovary] and
prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable
dose of less than or equal to 10 mg per day of prednisone or another oral
corticosteroid for at least 4 weeks before the first dose of study medication and
continue with the same dose throughout the study. If not using corticosteroids at
study initiation, the participant must have not received any oral corticosteroids for
at least 4 weeks before the first dose of study medication

- Participants currently treated with folic acid at a minimum dose of 5 mg per week

Exclusion Criteria:

- Participants having inflammatory disease other than RA

- Participant who have used any of the following medications: D-penicillamine,
hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine,
leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil

- Participant who have received intra-articular, intramuscular (into the muscle), or
intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone
(hormone made by the brain that activates the adrenal glands) within 4 weeks before
the first dose of the study medication

- Participants who have been treated with any other investigational drug or medical
device within 4 weeks or 5 half-lives of the drug, whichever is longer before the
first dose of study medication

- Participants who have undergone surgical treatments for RA including synoviectomy
(surgical removal of a part of the synovial membrane of a joint) and arthroplasty
(surgery to fix a joint) within 3 months before the first dose of study medication



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: JNJ 38518168

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12 [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change From Baseline in DAS28 (ESR) Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in HAQ-DI at Week 12 [Time Frame: Baseline and Week 12]

ACR-N Index Score [Time Frame: Week 12]

Percentage of Participants Achieving American College of Rheumatology (ACR20) Response [Time Frame: Week 12]

Percentage of Participants With DAS28 (CRP) Response [Time Frame: Week 12]

Change From Baseline in Participant's Assessment of Pain at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Participants Achieving ACR50 Response [Time Frame: Week 12]

Percentage of Participants With DAS28 (ESR) Response [Time Frame: Week 12]

Secondary ID(s)

2009-012118-27

38518168ARA2001

CR016414

Source(s) of Monetary Support

Please refer to primary and secondary sponsors