## Protocol Section
### Identification Module
**NCT ID:** NCT01555879

**Brief Title:** Real-world Clinical Efficacy of Abatacept in the T3 Data Registry

**Official Title:** Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups

#### Organization Study ID Info
**ID:** IM101-322
#### Organization
**Class:** INDUSTRY
**Full Name:** Arthritis Northwest PLLC
#### Secondary ID Infos
**Domain:** Arthritis Northwest
**ID:** ANW_20110816
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-11-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-11

**Type:** ACTUAL

#### Start Date
**Date:** 2012-03

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2012-03-16
**Type:** ESTIMATED
**Study First Submit Date:** 2012-02-29
**Study First Submit QC Date:** 2012-03-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Arthritis Northwest PLLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n \~= 200)".

**Detailed Description:** Two secondary hypotheses that will be tested are:

* Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender.
* A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.

### Conditions Module

**Conditions:**

- Arthritis, Rheumatoid

**Keywords:**

- Retrospective

- Database

- Data warehouse

- Data mining

- Collaborative effectiveness

- Comparative effectiveness

- Outcome based medicine

- Evidence based medicine

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.

**Intervention Names:**

- Drug: Abatacept

**Label:** All patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- All patients

**Description:** As prescribed by a doctor for patient medical care.

**Name:** Abatacept

**Other Names:**

- Orencia Intravenous

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

**Time Frame:** Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.

#### Secondary Outcomes

**Measure:** Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

**Time Frame:** Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 3 months.

**Measure:** Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.

**Time Frame:** Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosed with rheumatoid arthritis
* Have used Abatacept for 3 or more months

Exclusion Criteria:

* None

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** All rheumatoid arthritis patients from a single site who have been on Abatacept for greater than 3 months.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Spokane

**Country:** United States

**Facility:** Arthritis Northwest

**State:** Washington

**Zip:** 99208

#### Overall Officials

**Official 1:**

**Affiliation:** Arthritis Northwest PLLC

**Name:** Keith Knapp, Ph.D.

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Arthritis Northwest PLLC

**Name:** Gary Craig, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Michael Schiff, Coralie Poncet, and Manuela Le Bars International Journal of Clinical Rheumatology 2010 5:5, 581-591

**Citation:** Pincus T, Swearingen CJ, Bergman M, Yazici Y. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol. 2008 Nov;35(11):2136-47. doi: 10.3899/jrheum.080182. Epub 2008 Sep 15.

**PMID:** 18793006

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- 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: LOW

- As Found: Unknown

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Arthritis, Rheumatoid

- 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: 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

### Intervention Browse Module - Browse Leaves

- ID: M483

- Name: Abatacept

- Relevance: HIGH

- As Found: Panel

- 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
