Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959036

Enrollment

252

Registered

2009-08-14

Start date

2009-09-30

Completion date

2011-01-31

Last updated

2013-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Rheumatoid Arthritis

Brief summary

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

Interventions

DRUGATN-103

10 mg every 4 weeks until week 12

DRUGPlacebo

Placebo every 4 weeks

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

Exclusion criteria

* Any significant health problem other than rheumatoid arthritis * Any clinically significant laboratory abnormalities * Any prior use of B cell-depleting therapy

Design outcomes

Primary

Measure	Time frame
American College of Rheumatology (ACR) 20 response at week 16	6 months

Secondary

Measure	Time frame
Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments	6 months

Countries

Belgium, Canada, Germany, Hungary, Russia, Serbia, South Africa, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026