Trial Outcomes & Findings for Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA) (NCT NCT02094326)

NCT ID: NCT02094326

Last Updated: 2016-03-08

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 301 participants
• Primary outcome timeframe: 6 years
• Results posted on: 2016-03-08

Participant Flow

Participant milestones

Measure	Patients Whom Fulfilled the ACR Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Overall Study STARTED	301
Overall Study COMPLETED	301
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Age, Continuous	56.6 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	214 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice	65.1 percentage of participants Interval 63.3 to 74.3

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question	10.5 percentage of participants Interval 7.0 to 14.9

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal	16.1 percentage of participants Interval 11.9 to 21.1

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment	6.9 percentage of participants Interval 4.1 to 10.7

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Percentage of Patients Who Receive Subcutaneous Methotrexate	21.2 percentage of participants Interval 16.3 to 26.7

SECONDARY outcome

Timeframe: 6 years

methotrexate

Outcome measures

Measure	Patients Whom Fulfilled the ACR n=301 Participants Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
Exposure Time of Methotrexate	19.2 months Standard Deviation 16.5

Adverse Events

Patients Whom Fulfilled the ACR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Federico Navarro Sarabia

Hospital Virgen de la Macarena

Phone: +34 955 00 80 00

Email: federico.navarro.sarabia@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place