A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

July 6, 2017 updated by: Hoffmann-La Roche

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T5M 0H4
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 3G8
      • Vancouver, British Columbia, Canada, V5Z 3Y1
      • Victoria, British Columbia, Canada, V8V 3P9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
      • St John's, Newfoundland and Labrador, Canada, A1C 5B8
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
      • Hamilton, Ontario, Canada, L8S 4J9
      • Mississauga, Ontario, Canada, L5M 2V8
      • Nepean, Ontario, Canada, K2G 6E2
      • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa, Ontario, Canada, K1S 1C2
      • Thunder Bay, Ontario, Canada, P7B 5G3
      • Toronto, Ontario, Canada, M4K 1N2
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, M5G 1X5
      • Windsor, Ontario, Canada, N8X 5A6
    • Quebec
      • Laval, Quebec, Canada, H7G 2E6
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H2L 1S6
      • Montreal, Quebec, Canada, H2L 4M1
      • Quebec City, Quebec, Canada, G1V 3M7
      • Sainte-foy, Quebec, Canada, G1W 4R4
      • Sherbrooke, Quebec, Canada, J1H 5N4
      • St-eustache, Quebec, Canada, J7P 4J2
      • Trois-rivieres, Quebec, Canada, G8Z 1Y2
  • Sweden
      • Boras, Sweden, 50182
      • Falun, Sweden, 79182
      • Goeteborg, Sweden, 41345
      • Jonkoping, Sweden, 551 85
      • Kalmar, Sweden, 39185
      • Karlskrona, Sweden, 37185
      • Lulea, Sweden, 97180
      • Malmoe, Sweden, 20502
      • Oskarstroem, Sweden, 31392
      • Skoevde, Sweden, 54185
      • Stockholm, Sweden, 18288
      • Sundsvall, Sweden, 85186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18-80 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response to a single previous or current treatment with an anti-TNF agent
  • Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion Criteria:

  • Previous treatment with MabThera
  • Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
  • Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
  • Active infection, or history of serious or chronic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm
Drug: rituximab
1000 mg intravenously on Days 1 and 15

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary
Time Frame: Days 1, 2, 15, and 16 and Week 48 of Initial treatment period
Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Days 1, 2, 15, and 16 and Week 48 of Initial treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary
Time Frame: Days 1, 2, 15, and 16 and Week 48 of Re-treatment period
Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Days 1, 2, 15, and 16 and Week 48 of Re-treatment period
Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
ACR20/50/70, defined as ≥20 percent (%), 50%, or 70% improvement, respectively, compared to baseline in tender joint count (TJC) and swollen joint count (SJC), and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and an acute phase reactant (erythrocyte sedimentation rate [ESR] or C-Reactive Protein [CRP]). If CRP was missing or not done, then ESR was used.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Complete clinical response was defined as having an ACR70 for at least 13 weeks.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
ACR20/50/70, defined as ≥20%, 50%, or 70% improvement, respectively, compared to baseline in TJC and SJC, and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; HAQ-DI; and an acute phase reactant (ESR or CRP). If CRP was missing or not done, then ESR was used.
Weeks 12 and 24 of Re-treatment period
Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Complete clinical response was defined as having an ACR70 for at least 13 weeks.
Weeks 12 and 24 of Re-treatment period
Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score less than or equal to [≤]3.2), moderate (DAS28 score greater than [>]3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in DAS28 During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in DAS28 During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
The DAS28 scoring used 4 core components: SJC, TJC, Patient Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in SJC During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in SJC During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in TJC During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in TJC During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Physician Global Assessment of Disease Activity was measured using a 100-mm visual analog scale (VAS) where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Physician Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance
Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.
Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance
Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.
Weeks 12 and 24 of Re-treatment period
Change From Baseline HAQ-DI Score During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determined the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if > 2 categories were missing.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline HAQ-DI Score During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determines the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if >2 categories were missing.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in ESR During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in ESR During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in CRP During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline CRP During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
CRP levels were measured in mg/L and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.
Weeks 12 and 24 of Re-treatment period
Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
The DAS28 scoring used 4 core components: SJC, TJC, Patient's Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.
Weeks 12 and 24 of Re-treatment period
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period
Time Frame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Change From Baseline in FACIT-F Total Score During the Re-Treatment Period
Time Frame: Weeks 12 and 24 of Re-treatment period
Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.
Weeks 12 and 24 of Re-treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML20381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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