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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

ILV-094

Placebo

ILV-094

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, ACR, Methotrexate, Interleukin-22

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arizona Arthritis & Rheumatology Research, PLLC
Desert Medical Advances
Arthritis Center
Clinical Research Advantage, Inc.
The Arthritis Specialty Centre
Diagnostic Rheumatology and Research PC
Clayton Medical Research
Deaconess Hospital
Altoona Center for Clinical Research
Clinical Research Center of Reading
Clinical Research Center of Reading, LLC
Arthritis Care and Diagnostic Center
Arthritis & Osteoporosis Center of South Texas
AZ Jan Palfijn
Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL
Universitair Ziekenhuis Gent
Reuma Instituut
Chu Liege Sart Tilman B 35
Centro de Reumatologia y Ortopedia
Fundacion Instituto de Reumatologia Fernando Chalem
Medicity S.A.S
Servimed EU
University Hospital Centre Rijeka
University Hospital Center Zagreb
Klinikum Innenstadt der Ludwig-Maximillians-Universität
Budai Irgalmasrendi Hospital
Obudai Egeszsegugyi Centrum Kft
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Markusovszky Hospital
National Hospital Organization Shimoshizu National Hospital
Gunma University Hospital
National Hospital Organization Sagamihara National Hospital
Medical Corporation Wakoukai Kurashiki Kousai Hospital
Institute of Rheumatology, Tokyo Women's Medical University Hospital
Inoue Hospital
Matsubara Clinic
Matsubara Mayflower Hospital
Centro de Estudio de Investigacion Basica y Clinica S.C
AMC
Centrul Medical Terra Med
SC Duo Medical SRL
Spitalul Clinic Sf. Maria
Spitalul Clinic Colentina
Centrul de Boli Reumatismale Dr. I. Stoia
Spitalul Clinic Judetean de Urgenta Tg Mures
Municipal Institution City Clinical Hospital #40
Institute of Rheumatology of Russian academy of Medical Scie
City Clinical Hospital # 1 n.a. Pirogov
State Educational Institution of Additional Professional Education
State Health care institution of Leningrad Regional Clinical Hospital
State education institution of higher vocational education Smolensk State Medical Academy Roszdrav
State Healthcare Institution Yaroslavl Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Part 1: Placebo

Part 1: 100 mg ILV-094 SC Q4W

Part 1: 100 mg ILV-094 SC Q2W

Part 2: 200 mg ILV-094 SC Q2W

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12

ACR20 response: greater than or equal to (>=) 20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

Secondary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10

ACR20 response: >=20 percent improvement in tender joint count; >=20 percent improvement in swollen joint count; and >=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12

ACR50 response: >=50 percent improvement in tender joint count; >=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12

ACR70 response:>=70 percent improvement in tender joint count; >=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 [very well] to 10 [worst]); participant's assessment of pain (score: 0 [very well] to 100 [extremely bad]); physician global assessment of disease activity (score: 0 [very well] to 10 [worst]); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]) (score: 0 [no difficulty] to 3 [unable to do]); and C-reactive protein (CRP).

Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)

DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter [mg/L]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm [very well] to 100mm [extremely bad]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 implied remission.

Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)

DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour [mm/hour]); and general health VAS score (participant rated scale with scores ranging from 0 [very well] to 100 [extremely bad]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6 implied remission.

Tender Joints Counts (TJC)

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.

Swollen Joints Count (SJC)

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.

Physician Global Assessment of Disease Activity

Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

Participant Global Assessment of Disease Activity

Participants answered: "considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.

Pain Visual Analog Scale (VAS)

Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain.

General Health Visual Analog Scale (VAS)

General health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health currently concerning the arthritis?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.

Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

36-Item Short-Form Health Survey (SF-36)

SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning.

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, "I have energy" and "I am able to do my usual activities"), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

DAS28-based EULAR response criteria was used to measure individual response as none, good and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.

Full Information

NCT ID

NCT00883896

First Posted

April 17, 2009

Last Updated

September 23, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00883896

Brief Title

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

Official Title

RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

June 18, 2009 (Actual)

Primary Completion Date

February 18, 2011 (Actual)

Study Completion Date

February 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, ACR, Methotrexate, Interleukin-22

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Placebo Comparator

Arm Description

Part 1: Placebo

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Part 1: 100 mg ILV-094 SC Q4W

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

Part 1: 100 mg ILV-094 SC Q2W

Arm Title

Arm 4

Arm Type

Placebo Comparator

Arm Title

Arm 5

Arm Type

Experimental

Arm Description

Part 2: 200 mg ILV-094 SC Q2W

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Part 1: Placebo SC administration every 2 weeks X 10 weeks.

Intervention Type

Drug

Intervention Name(s)

ILV-094

Intervention Description

Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.

Intervention Type

Drug

Intervention Name(s)

ILV-094

Intervention Description

Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Part 2: Placebo SC administration every 2 weeks X 10 weeks

Intervention Type

Drug

Intervention Name(s)

ILV-094

Intervention Description

Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10

Description

Time Frame

Week 2, 4, 6, 8, 10

Title

Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12

Description

Time Frame

Week 2, 4, 6, 8, 10, 12

Title

Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12

Description

Time Frame

Week 2, 4, 6, 8, 10, 12

Title

Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)

Description

Time Frame