Study of the Treatment of Algerian Patients With Early Rh... | NCT02008266

Studies
Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis

NCT02008266

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Dec 11, 2013Estimated

Enrollment

532Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 27, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2013

Last Update Posted Date

Dec 11, 2013Estimated

Description Module

Brief Summary

This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

532Actual

Label	Type	Description	Intervention Names
Patients with Rheumatoid Arthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.		Single observational visit [Day 1]

Secondary Outcomes

Measure	Description	Time Frame
Measure disease activity using DAS 28 assessment.		Single observational visit [Day 1]
Assess joint damage using the modified SHARP method.		Single observational visit [Day 1]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rheumatoid arthritis progressing for < 2 years.

Exclusion Criteria:

Rheumatoid arthritis progressing for < 3 months.
Rheumatoid arthritis onset at < 18 years of age.
Participation in another clinical study.
Rheumatoid arthritis related connective tissue disorder.
Any neuropsychological disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Rheumatoid Arthritis that has been progressing for > 3 months and < 2 years.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided