A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718588

Enrollment

Registered

2008-07-18

Start date

2008-07-31

Completion date

Unknown

Last updated

2012-03-07

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

Conditions

Rheumatoid Arthritis

Keywords

Brief summary

This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.

Interventions

DRUGMTRX1011A

Subcutaneous and intravenous single and repeating dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. SAD Stage * RA diagnosed according to the ACR * For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization * Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period 2. MAD Stage (same as above with the addition of the following) * Failure of at least one biologic agent, defined as lack of or loss of response or intolerance * Active disease defined by swollen and tender count

Exclusion criteria

* Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome * Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected * History of treatment with any T cell-directed therapy

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of MTRX1011A in both the SAD and MAD stages	Length of study

Secondary

Measure	Time frame
Characterize the pharmacokinetic response of MTRX1011A	Length of study
Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A	Length of study

Outcome results

None listed

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