Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00883896

Collaborator

(none)

195

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Other: Placebo Drug: ILV-094 Drug: ILV-094 Other: Placebo Drug: ILV-094	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of ILV-094 Administered Subcutaneously To Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 Part 1: Placebo	Other: Placebo Part 1: Placebo SC administration every 2 weeks X 10 weeks.
Experimental: Arm 2 Part 1: 100 mg ILV-094 SC Q4W	Drug: ILV-094 Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
Experimental: Arm 3 Part 1: 100 mg ILV-094 SC Q2W	Drug: ILV-094 Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.
Placebo Comparator: Arm 4	Other: Placebo Part 2: Placebo SC administration every 2 weeks X 10 weeks
Experimental: Arm 5 Part 2: 200 mg ILV-094 SC Q2W	Drug: ILV-094 Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks

Outcome Measures

Primary Outcome Measures

American College of Rheumatology (ACR) 20% improvement criteria [Week 12]

Secondary Outcome Measures

ACR20 at other time points, ACR50, ACR70, DAS28, EULAR response, tender and swollen joints assessments, physician and patient global assessments, Pain Visual Analog Scale, health outcome assessments [Up to Week 22]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
Active RA at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion Criteria:

Subjects with other rheumatic diseases
Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
Any prior use of B cell-depleting therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Glendale	Arizona	United States	85304
2	Pfizer Investigational Site	Palm Desert	California	United States	92260
3	Pfizer Investigational Site	Palm Harbor	Florida	United States	34684
4	Pfizer Investigational Site	Sarasota	Florida	United States	34233
5	Pfizer Investigational Site	Indianapolis	Indiana	United States	56227
6	Pfizer Investigational Site	St Louis	Missouri	United States	63117
7	Pfizer Investigational Site	Cincinnati	Ohio	United States	45219
8	Pfizer Investigational Site	Duncansville	Pennsylvania	United States	16635
9	Pfizer Investigational Site	West Reading	Pennsylvania	United States	19611
10	Pfizer Investigational Site	Dallas	Texas	United States	75231
11	Pfizer Investigational Site	San Antonio	Texas	United States	78232
12	Pfizer Investigational Site	Antwerpen		Belgium	2170
13	Pfizer Investigational Site	Brussels		Belgium	1200
14	Pfizer Investigational Site	Gent		Belgium	9000
15	Pfizer Investigational Site	Hasselt		Belgium	3500
16	Pfizer Investigational Site	Liege		Belgium	4000
17	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia
18	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
19	Pfizer Investigational Site	Bucaramanga	Santander	Colombia
20	Pfizer Investigational Site	Rijeka		Croatia	51000
21	Pfizer Investigational Site	Zagreb		Croatia	10000
22	Pfizer Investigational Site	München		Germany	80336
23	Pfizer Investigational Site	Budapest		Hungary	1023
24	Pfizer Investigational Site	Budapest		Hungary	1036
25	Pfizer Investigational Site	Nyiregyhaza		Hungary	4400
26	Pfizer Investigational Site	Szombathely		Hungary	9700
27	Pfizer Investigational Site	Yotsukaidou	Chiba	Japan
28	Pfizer Investigational Site	Maebashi	Gunma	Japan
29	Pfizer Investigational Site	Sagamihara	Kanagawa	Japan
30	Pfizer Investigational Site	Kurashiki	Okayama	Japan
31	Pfizer Investigational Site	Shinjyuku-ku	Tokyo	Japan
32	Pfizer Investigational Site	Gunma		Japan
33	Pfizer Investigational Site	Hyogo		Japan
34	Pfizer Investigational Site	Jalisco	Guadalajara	Mexico	44690
35	Pfizer Investigational Site	Amsterdam	Noord-Holland	Netherlands	1105AZ
36	Pfizer Investigational Site	Cluj-Napoca	Cluj	Romania	400275
37	Pfizer Investigational Site	Bucuresti		Romania	010584
38	Pfizer Investigational Site	Bucuresti		Romania	011172
39	Pfizer Investigational Site	Bucuresti		Romania	020125
40	Pfizer Investigational Site	Bucuresti		Romania	020983
41	Pfizer Investigational Site	Targu Mures		Romania	540136
42	Pfizer Investigational Site	Ekaterinburg		Russian Federation	620102
43	Pfizer Investigational Site	Moscow		Russian Federation	115522
44	Pfizer Investigational Site	Moscow		Russian Federation	119049
45	Pfizer Investigational Site	Smolensk		Russian Federation	214019
46	Pfizer Investigational Site	St. Petersburg		Russian Federation	194291
47	Pfizer Investigational Site	St.Petersburg		Russian Federation	191015
48	Pfizer Investigational Site	St.Petersburg		Russian Federation	194291
49	Pfizer Investigational Site	Yaroslavl		Russian Federation	150062