Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 26 August 2024
• Main ID: NCT00815906
• Date of registration: 18/12/2008
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
• Scientific title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
• Date of first enrolment: December 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00815906
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must meet American College of Rheumatology criteria for rheumatoid arthritis with
functional class I to III.

- Rheumatoid arthritis disease onset at >16 years of age and duration of disease at
least 6 months.

- Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive
at the screening visit.

Exclusion Criteria:

- Any significant health problems other than rheumatoid arthritis.

- Treatment of greater than 10 mg of prednisone per day.

- Therapy with immunosuppressants within 6 months before study day 1


Age minimum: 20 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: SBI-087

Primary Outcome(s)

Safety and tolerability as determined by the number and severity of adverse events at the different dose levels [Time Frame: 12 months]

Secondary Outcome(s)

To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087 [Time Frame: 12 month]

To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA [Time Frame: 12 months]

To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087 [Time Frame: 12 month]

Secondary ID(s)

3227K1-1001

B2261002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Emergent Product Development Seattle LLC