Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Methylprednisolone; Drug: TRU-015; Drug: Prednisone

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00634933

B2051001

3206K1-2203

Details and patient eligibility

About

This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.

Exclusion criteria

• Any prior use of rituximab or other B cell depleting agents.
• Any significant health problem other than rheumatoid arthritis
• Clinically significant laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Consists of Arms 1a and 1b

Treatment:

Drug: Methylprednisolone

Drug: TRU-015

Drug: Prednisone

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015

Arm 2

Experimental group

Description:

Consists of Arms 2a and 2b

Treatment:

Drug: Methylprednisolone

Drug: TRU-015

Drug: Prednisone

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015

Arm 3

Placebo Comparator group

Description:

Consists of Arms 3a and 3b.

Treatment:

Drug: Methylprednisolone

Drug: TRU-015

Drug: Prednisone

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015

Drug: Methylprednisolone

Drug: Prednisone

Drug: TRU-015