A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies

Hexal AG0 sites124 target enrollmentFebruary 6, 2015

ConditionsRefractory rheumatoid arthritis MedDRA version: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsRituxan (INN: Rituximab), brand name in the United States

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Refractory rheumatoid arthritis
Sponsor: Hexal AG
Enrollment: 124
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 6, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Hexal AG

Eligibility Criteria

Inclusion Criteria

•Patients eligible for inclusion in this study have to fulfill all of the following criteria:
•1\. Patients must give written informed consent before any study\-related assessment is performed.
•2\. Patients must be \= 18 years of age.
•3\. Patients must have a diagnosis of Rheumatoid Arthritis, based on the ACR 1987 criteria.
•At least 4 of the following 7 criteria must be fulfilled (and criteria a. through d. must have been present for at least 6 weeks) to confirm the diagnosis of RA:
•a. joint morning stiffness of at least one hour
•b. swelling of joints in at least three joint areas, diagnosed by a doctor, c. swelling of MCP and wrist joints, diagnosed by a doctor
•d. bilateral, symmetric swelling of joints in the same joint areas, diagnosed by a doctor
•e. rheumatoid nodule
•f. rheumatoid factor seropositivity

Exclusion Criteria

•Patients eligible for inclusion in this study must not fulfill any of the following criteria:
•1\. RA patients with functional status class IV classified according to the ACR 1991 revised criteria.
•2\. Patients with levels of serum IgG, IgM and IgA below LLN at Visit 1 and/or Visit 2\.
•3\. Patients with systemic manifestations of RA, with the exception of Sjögren’s syndrome.
•4\. Patients taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine).
•5\. Female patients nursing (lactating / breast\-feeding), pregnant or planning of pregnancy within 12 months after the last infusion of study drug, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (cut\-off as defined by the central laboratory).
•6\. Women of child\-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post\-ovulation methods) is not acceptable.
•7\. Patients who have had any therapy with intra\-articular injections (e. g. corticoid) required by a flare up to 4 weeks before randomization.
•For additional exclusion criteria, please refer to section 4\.2 of the protocol.