A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-022378-15-ES
• Lead Sponsor: ycomed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Written informed consent obtained before any trial-related activities
- Outpatient, male or female, at least 18 years of age at Screening
- Active rheumatoid arthritis. Diagnosis of RA using the ACR criteria for
the classification of RA for at least 6 months prior to trial entry (based
on swollen and tender joint count; CRP and/or ESR; RF and/or anti-CCP)
- An inadequate response to previous or current treatment with either
MTX alone or a combination of MTX plus anti-tumor necrosis factor alpha
biologic agents.
- Receiving MTX 15-25 mg/week (oral or parenteral) for at least 20
weeks, including the last 6 weeks prior to Baseline at a stable dose
- Subjects of reproductive potential (females and males) must agree to
use effective double-method contraception
- Female subjects must not be actively breast-feeding
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Medical history/concurrent diseases
Joints
- Subjects who are wheel chair or bed bound
- Rheumatic autoimmune disease other than RA, or significant systemic
involvement secondary to RA
- History of or current inflammatory joint disease other than RA
- Septic prosthetic joint within the last 48 weeks prior to Baseline or
indefinitely if the prosthesis concerned remains in situ.
Infectious diseases
- Primary or secondary immunodeficiency, including human
immunodeficiency virus (HIV) infection
- Evidence of acute or chronic infection with hepatitis B virus (HBV) or
hepatitis C virus (HCV)
- Evidence and/or history of active tuberculosis (TB), prior to
successfully completing an anti-TB treatment. Subjects with latent TB
infection (LTBI) can be included
- Acute clinical manifestations of herpes zoster virus and history of
severe herpes zoster
- History of active infection of any kind or any major episode of infection
requiring hospitalisation or treatment with iv anti infective agents within
6 weeks prior to Baseline or oral anti-infective agents within 2 weeks
prior to Baseline
- History of deep space/tissue infection within 48 weeks prior to
Baseline
- History of osteomyelitis
- History of sepsis of any origin requiring intensive care
- History of serious recurrent or chronic infections not specified above.
Cardio-pulmonary
- Any significant cardiac disease
- History of severe chronic obstructive pulmonary disease (COPD)
and/or history of severe COPD exacerbation(s) within the last 12
months prior to Screening .
Immune system/haematology/biochemistry
- History of a severe allergic reaction or anaphylactic reaction to a
biological agent or history of hypersensitivity to any component of
veltuzumab injection solution
- Subjects with CD4 cell counts (< 250/?l) at Screening
- Hypogammaglobulinemia (IgG < 5.0 g/L, and/or IgM < 0.20 g/L) at
Screening
- Splenectomy
- Subjects with haemoglobin < 9.0 g/dL, white blood cell (WBC) count <
3000 cells/?L, absolute neutrophil count (ANC) < 2000 cells/?L,
lymphocyte count < 800 cells/?L or platelet count < 100,000/?L at
Screening
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT),
gamma-glutamyl transpeptidase (GGT) or alkaline phosphatase levels >
2.0 times the upper limit of normal (ULNR) at Screening
- Subjects with a serum creatinine > ULNR (e.g. > 1.2 mg/dL for males
and > 1.0 mg/dL for females) at Screening
Other medical conditions
- Subjects with diabetes mellitus type 1 or unstable type 2
- History of solid-organ transplantation
- History of cancer within the last 5 years treated with anti-cancer
chemotherapy
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- Current active alcohol or drug abuse or history of alcohol or drug abuse
within 24 weeks prior to Baseline. Opiate-containing medicines are not
allowed
- Evidence of any significant and/or unstable concomitant diseases such
as nervous system, renal, hepatic, endocrine, respiratory or
gastrointestinal disorders which, in the Investigator's opinion, would
preclude subject participation
- Any other medical condition (e.g. clinically relevant abnormal
laboratory values) that would, in the Investigator's opinion, make the
administration of trial drug or trial procedures hazardous to the subject,
or obscure the interpretation of AEs.
Skin
- Chronic skin ulcerations.
Previous and concomitant therapies and procedures
- Any planned, elective or emergency surgical procedure, including bone
or joint surgery/synovectomy wit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified