A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01231321

First received: October 28, 2010

Last updated: April 20, 2011

Last verified: April 2011

Results First Received: February 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Drug: adalimumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Participant Flow: Overall Study

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
STARTED	100
COMPLETED	95
NOT COMPLETED	5
Adverse Event	3
Lack of Efficacy	2

Baseline Characteristics

Reporting Groups

	Description
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Baseline Measures

	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL
Number of Participants [units: participants]	100
Age [units: participants]
<=18 years	0
Between 18 and 65 years	90
>=65 years	10
Age [units: years] Mean ± Standard Deviation	50.9 ± 11.1
Gender [units: participants]
Female	89
Male	11
Region of Enrollment [units: participants]
Russian Federation	100