A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.

Conditions: Rheumatoid Arthritis
Classification code 10039073

Registration Number: EUCTR2005-002326-63-EE

Lead Sponsor: CB Celltech

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 590

Inclusion Criteria

1. Patients must be at least 18 years old at the screening visit.

2. Patients must have a clear chest X–ray within three months prior to the Baseline visit (negative for TB).

3. Female patients of childbearing potential must have a negative serum pregnancy test at the screening visit and negative urine testing immediately before every certolizumab pegol administration. Females must be surgically sterile, postmenopausal for at least 2 years prior to screening visit, must have undergone tubal ligation or be using an acceptable method of birth control for the duration of the study and for 12 weeks after the last dose of certolizumab pegol. Oral contraceptives must be stable for at least 28 days prior to screening visit. Abstinence is not an acceptable method of contraception for the study.

4. Patients must have a diagnosis of adult–onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.

5. Patients must have active RA disease as defined by:
=9 tender joints at Screening and Baseline.
=9 swollen joints at Screening and Baseline.
and fulfilling 1 of the following 2 criteria during the screening period:
a) =30 mm/hour ESR (Westergren),
or
b) CRP >15 mg/L.

6. Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

7. Patients must be willing to complete an X–ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

8. Patients must be able to understand the information provided to them and to give written Informed Consent.
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 Exclusions:

1. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).

2. Patients must not have 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 study drug on the patient’s primary diagnosis of RA.

3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. Concomitant medication exclusions

4. Patients must be free of prohibited medication as detailed on page 33 & 34 of the protocol.

Previous clinical trials and previous biological therapy exclusion:

5. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit.

6. Patients must not have received any biological therapy for RA within six months prior to Baseline visit, except for etanercept and anakinra where a three month washout prior to baseline visit is acceptable.

7. Patients must not have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.

8. Patients who failed to respond to previous treatment with an anti–TNF drug are excluded. Patients who initially responded to a previous treatment with an anti-TNF drug but who later discontinued that drug due to loss of efficacy or other reasons may be included.

Medical History Exclusion:

9. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.

10. Patients with a history of chronic infection, recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.

11. Patients with a history of tuberculosis or positive chest X–ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test. Patients with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator. Consideration should be given to the fact that a positive PPD skin test with prior vaccination does not exclude latent TB.

12. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).

13. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.

14. Patients with a known positive hepatitis B surface antigen test and/or hepatitis C antibody test result.

15. Patients with known human immunodeficiency virus (HIV) infection.

16. Patients receiving any vaccination (live or attenuated) within eight weeks prior to Baseline. (However, influenza and pneumococcal vaccines are allowed).

17. Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).

18. Patients with a history of blood dyscrasias.

19. Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gast