A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027

Conditions: Rheumatoid arthritis
Classification code 10039073

Registration Number: EUCTR2005-001350-24-LT

Lead Sponsor: CB Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

Patients must have either failed to achieve an ACR20 response at Weeks 12 and 14 in CDP870-027, or must have completed the entire Week 52 assessment of CDP870-027 trial.

Female patients must be either postmenopausal for at least one year, surgically incapable of child bearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method). Patients must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of study medication (or longer if required by local regulations).

Patients must have a clear chest X-ray at Entry visit.

Patients must be able to understand the information provided to them and to give written Informed Consent for CDP870-028.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

RA Disease Related:
1. A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.

2. A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient’s primary diagnosis of RA.

3. A history of an infected joint prosthesis at any time with prosthesis still in situ.

4. Concomitant medication exclusion:
Any biological therapy.
Any experimental therapy, within or outside a clinical trial.

Medical History Exclusion
5. Lactating and/or pregnant female patients.

6. Female patients of child bearing are who are NOT practicing effective birth control (see Inclusion Criteria 2). All female patients must test negative on a urine pregnancy test before study entry and at each study visit

7. Serious or life-threatening infection (including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough).

8. Clinical or radiographic evidence of Tuberculosis (TB) at the Entry visit.

9. A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or a current sign or symptom that may indicate an infection (e.g. fever, cough).

10. Patients at a high risk of infection in the Investigator’s opinion (e.g. patients with leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).

11. A known positive hepatitis B surface antigen test and/or hepatitis C antibody test result.

12. Known human immunodeficiency virus (HIV) infection.

13. Lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.

14. A history of blood dyscrasias.

15. Active malignancy of any type.

16. Severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.

17. New York Heart Association (NYHA) class III-IV congestive heart failure.

18. Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

19. An adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.

20. Any other condition, which in the Investigator’s judgment would make the patient unsuitable for inclusion in the study.