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

Ablynx

Status and phase: Completed; Phase 2; Phase 1

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Placebo; Drug: ATN-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959036

B2271003

3242K1-2000

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 6 patient groups, including a placebo group

Treatment Group 1

Experimental group

Description:

ATN-103 10 mg every 4 weeks until week 12

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: Methotrexate

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Treatment Group 2

Experimental group

Description:

ATN-103 10 mg every 8 weeks until week 12

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: Methotrexate

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Treatment Group 3

Experimental group

Description:

ATN-103 30 mg every 4 weeks until week 12

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: Methotrexate

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Treatment Group 4

Experimental group

Description:

ATN-103 80 mg every 4 weeks until week 12

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: Methotrexate

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Treatment Group 5

Experimental group

Description:

ATN-103 80 mg every 8 weeks until week 12

Treatment:

Drug: ATN-103

Drug: ATN-103

Drug: Methotrexate

Drug: ATN-103

Drug: ATN-103

Drug: ATN-103

Treatment Group 6

Placebo Comparator group

Description:

Placebo every 4 weeks

Treatment:

Drug: Methotrexate

Drug: Placebo