Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

• ClinicalTrials.gov Identifier: NCT01230177
• Recruitment Status: Completed
• First Posted: October 28, 2010
• Results First Posted: February 23, 2017
• Last Update Posted: February 23, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Condition or disease	Intervention/treatment
Arthritis; Rheumatoid	Drug: etanercept (genetical recombination)

Detailed Description:

Implemented as a Special Investigation by Central Registration System

Study Design

• Study Type: Observational
• Actual Enrollment: 3 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
• Study Start Date: May 2011
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
Etanercept (genetical recombination); Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.	Drug: etanercept (genetical recombination); 10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.; Other Name: Enbrel

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Treatment Related Adverse Events [ Time Frame: 12 weeks ]
   Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
2. Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) [ Time Frame: 12 weeks ]

   DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

   DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

3. Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) [ Time Frame: 12 weeks ]

   DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

   DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

Secondary Outcome Measures :

1. Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values [ Time Frame: 12 weeks ]
   On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Criteria

Inclusion Criteria:

• Patients need to be administered etanercept in order to be enrolled in the survey
• Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion Criteria:

• Patients who have been administered etanercept 50mg once a week
• Patients who have been administered etanercept 25mg once a week

Contacts and Locations

Locations

Japan

Taihaku Sakura Hospital

Sendai, Miyagi, Japan, 982-0032

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01230177
• Other Study ID Numbers: B1801134
• First Posted: October 28, 2010
• Results First Posted: February 23, 2017
• Last Update Posted: February 23, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Arthritis; Joint Diseases; Musculoskeletal Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors