## Protocol Section
### Identification Module
**NCT ID:** NCT00162279

**Brief Title:** The Study of Abatacept in Combination With Etanercept

**Official Title:** A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis

#### Organization Study ID Info
**ID:** IM101-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2010-09-14

**Type:** ESTIMATED

**Disp First Submit Date:** 2010-09-10
**Disp First Submit QC Date:** 2010-09-10

#### Last Update Post Date
**Date:** 2010-12-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-12-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Start Date
**Date:** 2000-10

**Status Verified Date:** 2010-12

#### Study First Post Date
**Date:** 2005-09-13
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-09
**Study First Submit QC Date:** 2005-09-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

### Description Module

**Brief Summary:** The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 141

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Abatacept

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone

**Time Frame:** at 6 months

#### Secondary Outcomes

**Measure:** ACR 50 and 70 will be evaluated

**Time Frame:** at 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All subjects who had completed the short term portion of IM101-101.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Huntsville

**Country:** United States

**Facility:** Local Institution

**State:** Alabama

**Location 2:**

**City:** La Jolla

**Country:** United States

**Facility:** Local Institution

**State:** California

**Location 3:**

**City:** Long Beach

**Country:** United States

**Facility:** Local Institution

**State:** California

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** Local Institution

**State:** California

**Location 5:**

**City:** Palo Alto

**Country:** United States

**Facility:** Local Institution

**State:** California

**Location 6:**

**City:** San Francisco

**Country:** United States

**Facility:** Local Institution

**State:** California

**Location 7:**

**City:** Denver

**Country:** United States

**Facility:** Local Institution

**State:** Colorado

**Location 8:**

**City:** Ft. Lauderdale

**Country:** United States

**Facility:** Local Institution

**State:** Florida

**Location 9:**

**City:** Titusville

**Country:** United States

**Facility:** Local Institution

**State:** Florida

**Location 10:**

**City:** Rome

**Country:** United States

**Facility:** Local Institution

**State:** Georgia

**Location 11:**

**City:** Chicago

**Country:** United States

**Facility:** Local Institution

**State:** Illinois

**Location 12:**

**City:** Hagerstown

**Country:** United States

**Facility:** Local Institution

**State:** Maryland

**Location 13:**

**City:** Boston

**Country:** United States

**Facility:** Local Institution

**State:** Massachusetts

**Location 14:**

**City:** Springfield

**Country:** United States

**Facility:** Local Institution

**State:** Massachusetts

**Location 15:**

**City:** Duluth

**Country:** United States

**Facility:** Local Institution

**State:** Minnesota

**Location 16:**

**City:** Lincoln

**Country:** United States

**Facility:** Local Institution

**State:** Nebraska

**Location 17:**

**City:** New Brunswick

**Country:** United States

**Facility:** Local Institution

**State:** New Jersey

**Location 18:**

**City:** Los Alamos

**Country:** United States

**Facility:** Local Institution

**State:** New Mexico

**Location 19:**

**City:** Albany

**Country:** United States

**Facility:** Local Institution

**State:** New York

**Location 20:**

**City:** Mineola

**Country:** United States

**Facility:** Local Institution

**State:** New York

**Location 21:**

**City:** New York

**Country:** United States

**Facility:** Local Institution

**State:** New York

**Location 22:**

**City:** Bismarck

**Country:** United States

**Facility:** Local Institution

**State:** North Dakota

**Location 23:**

**City:** Cincinnati

**Country:** United States

**Facility:** Local Institution

**State:** Ohio

**Location 24:**

**City:** Portland

**Country:** United States

**Facility:** Local Institution

**State:** Oregon

**Location 25:**

**City:** Duncansville

**Country:** United States

**Facility:** Local Institution

**State:** Pennsylvania

**Location 26:**

**City:** Norristown

**Country:** United States

**Facility:** Local Institution

**State:** Pennsylvania

**Location 27:**

**City:** Charleston

**Country:** United States

**Facility:** Local Institution

**State:** South Carolina

**Location 28:**

**City:** Knoxville

**Country:** United States

**Facility:** Local Institution

**State:** Tennessee

**Location 29:**

**City:** Austin

**Country:** United States

**Facility:** Local Institution

**State:** Texas

**Location 30:**

**City:** Dallas

**Country:** United States

**Facility:** Local Institution

**State:** Texas

**Location 31:**

**City:** Temple

**Country:** United States

**Facility:** Local Institution

**State:** Texas

**Location 32:**

**City:** Salt Lake City

**Country:** United States

**Facility:** Local Institution

**State:** Utah

**Location 33:**

**City:** Edmonds

**Country:** United States

**Facility:** Local Institution

**State:** Washington

**Location 34:**

**City:** Tacoma

**Country:** United States

**Facility:** Local Institution

**State:** Washington

**Location 35:**

**City:** Glendale

**Country:** United States

**Facility:** Local Institution

**State:** Wisconsin

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

### Intervention Browse Module - Ancestors

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M483

- Name: Abatacept

- Relevance: HIGH

- As Found: Panel

- ID: M311

- Name: Etanercept

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069594

- Term: Abatacept

### Misc Info Module

- Version Holder: 2024-05-24
