A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00152386

Collaborator

(none)

950

Enrollment

Locations

19.9

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol (CDP870)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline []

Secondary Outcome Measures

Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female, aged at least 18 years old at the Screening visit.
A clear chest X-ray within 3 months prior to Baseline visit.
A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
Active RA disease at Screening and Baseline as defined by:
≥9 tender joints.
≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
≥30 mm/hour ESR (Westergren), or
CRP >15 mg/L.
Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.

Exclusion Criteria:

A diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
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.
A history of an infected joint prosthesis at any time with prosthesis still in situ.
Does not meet exclusionary concomitant medication criteria.
A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).

Contacts and Locations

Locations

	City	State	Country
1	Huntsville	Alabama	United States
2	Paradise Valley	Arizona	United States
3	La Jolla	California	United States
4	San Diego	California	United States
5	Denver	Colorado	United States
6	Danbury	Connecticut	United States
7	Washington	District of Columbia	United States
8	Aventura	Florida	United States
9	Ocala	Florida	United States
10	Orlando	Florida	United States
11	Sarasota	Florida	United States
12	Tampa	Florida	United States
13	Coeur d'Alene	Idaho	United States
14	Springfield	Illinois	United States
15	Wichita	Kansas	United States
16	Wheaton	Maryland	United States
17	Saint Louis	Missouri	United States
18	Lincoln	Nebraska	United States
19	Charlotte	North Carolina	United States
20	Cleveland	Ohio	United States
21	Dayton	Ohio	United States
22	Duncansville	Pennsylvania	United States
23	Charleston	South Carolina	United States
24	Austin	Texas	United States
25	Dallas	Texas	United States
26	San Antonio	Texas	United States
27	Capital Federal		Argentina
28	Cordoba		Argentina
29	Camperdown		Australia
30	Coffs Harbour		Australia
31	Cotton Tree		Australia
32	Malvern		Australia
33	Shenton Park		Australia
34	Victoria Park		Australia
35	Westmead		Australia
36	Wooloongabba		Australia
37	Antwerpen		Belgium
38	Brussels		Belgium
39	Liege		Belgium
40	Merksem		Belgium
41	Sijsele		Belgium
42	Pleven		Bulgaria
43	Sofia		Bulgaria
44	Stara Zagora		Bulgaria
45	Varna		Bulgaria
46	Courtice		Canada
47	Hamilton		Canada
48	Kitchener		Canada
49	London		Canada
50	Mississauga		Canada
51	Montreal		Canada
52	Newmarket		Canada
53	Point Claire		Canada
54	Sainte Foy		Canada
55	Toronto		Canada
56	Winnipeg		Canada
57	Valdivia	Las Condes	Chile
58	Santiago	Santiago Centro	Chile
59	Santiago de Chile		Chile
60	Santiago		Chile
61	Temuco		Chile
62	Rijeka		Croatia
63	Brno Bohunice		Czechia
64	Brno		Czechia
65	Ostrava Trebovice		Czechia
66	Plzen		Czechia
67	Prague 2		Czechia
68	Praha 5		Czechia
69	Praha		Czechia
70	Uherske Hradiste		Czechia
71	Zlin		Czechia
72	Afula		Israel
73	Haifa		Israel
74	Ramat Gan		Israel
75	Tel Aviv		Israel
76	Riga		Latvia
77	Moscow		Russian Federation
78	St. Petersburg		Russian Federation
79	Ivano-Frankivsk		Ukraine