A Study 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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00160602

Collaborator

(none)

590

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Certolizumab Pegol	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24. []

Secondary Outcome Measures

Assess Safety and Tolerability of two dose regimens of certolizumab pegol in combination with MTX and MTX alone in patients with RA; prevention of joint damage in patients with RA; Health Outcomes Measures []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must be at least 18 years old at the screening visit.
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.
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:
30 mm/hour ESR (Westergren), or CRP >15 mg/L.
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.
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.

Exclusion Criteria:

Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
Patients must not have a secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia)
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.
Patients with a history of tuberculosis or positive chest X-ray for tuberculosis or positive
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).
Patients with known human immunodeficiency virus (HIV) infection.
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).
Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial.
Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

Contacts and Locations

Locations

	City	State	Country
1	Montgomery	Alabama	United States
2	Sun City West	Arizona	United States
3	Palm Desert	California	United States
4	Pasadena	California	United States
5	Santa Maria	California	United States
6	Naples	Florida	United States
7	Palm Harbor	Florida	United States
8	South Miami	Florida	United States
9	New Orleans	Louisiana	United States
10	Saint Louis	Missouri	United States
11	New Brunswick	New Jersey	United States
12	Stratford	New Jersey	United States
13	New York	New York	United States
14	Rochester	New York	United States
15	Canfield	Ohio	United States
16	Wynnewood	Pennsylvania	United States
17	San Antonio	Texas	United States
18	Pleven		Bulgaria
19	Sofia		Bulgaria
20	Stara Zagora		Bulgaria
21	Santiago		Chile
22	Temuco		Chile
23	Rijeka		Croatia
24	Brno		Czechia
25	Hlucin		Czechia
26	Ostrava-Poruba		Czechia
27	Praha 2		Czechia
28	Praha 5		Czechia
29	Sokolov		Czechia
30	UherskeHradiste		Czechia
31	Zlin		Czechia
32	Tallinn		Estonia
33	Afula		Israel
34	Ashkelon		Israel
35	Beer Yaakov		Israel
36	Haifa		Israel
37	Jerusalem		Israel
38	Ramat Gan		Israel
39	Rehovot		Israel
40	Daugavpils		Latvia
41	Riga		Latvia
42	Alytus		Lithuania
43	Kaunas		Lithuania
44	Klaipeda		Lithuania
45	Panevezys		Lithuania
46	Siauliai		Lithuania
47	D. F.		Mexico
48	Mexicalli		Mexico
49	Mexico		Mexico
50	Monterrey		Mexico
51	Tijuana		Mexico
52	Bialystok		Poland
53	Elblag		Poland
54	Krakow		Poland
55	Lublin		Poland
56	Sopot		Poland
57	Torun		Poland
58	Moscow		Russian Federation
59	St Petersburg		Russian Federation
60	Yaroslavl		Russian Federation
61	Belgrade		Serbia
62	Niska Banja		Serbia
63	Novi Sad		Serbia
64	Kosice		Slovakia
65	Piestany		Slovakia
66	Dnepropetrovsk		Ukraine
67	Donetsk		Ukraine
68	Ivano-Frankivsk		Ukraine
69	Kiev		Ukraine
70	Simferopol		Ukraine
71	Zaporozhye		Ukraine