NCT00282308|CompletedPhase 2Results

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

SIERRA

A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Genentech, Inc.ClinicalTrials.gov

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1 other identifier

U3374g

Study Type

interventional

Target

103

Locations

1 country

Sites

Timeline

RegisteredJan 2006

StartedJan 2006

CompletionMay 2012

Brief Summary

This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

103

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Jan 2006

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach

1 country

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

Study Start

First participant enrolled

January 23, 2006

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2008

Completed

4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2012

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2013

Completed

Last Updated

August 10, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

January 24, 2006

Results QC Date

June 5, 2013

Last Update Submit

July 11, 2017

Conditions

Rheumatoid Arthritis

Keywords

RARituxanSIERRA

Outcome Measures

Primary Outcomes (1)

Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.
Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B

Secondary Outcomes (9)

Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine
Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine
Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine
Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
+4 more secondary outcomes

Study Arms (2)

Rituximab + methotrexate (Group A)

EXPERIMENTAL

Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

Drug: RituximabDrug: MethotrexateDrug: MethylprednisoneBiological: C. albicansBiological: Tetanus toxoid adsorbed booster vaccineBiological: 23-valent pneumococcal polysaccharide vaccineBiological: Keyhole limpet hemocyanin

Methotrexate (Group B)

ACTIVE COMPARATOR

Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.

Drug: MethotrexateBiological: C. albicansBiological: Tetanus toxoid adsorbed booster vaccineBiological: 23-valent pneumococcal polysaccharide vaccineBiological: Keyhole limpet hemocyanin

Interventions

RituximabDRUG

Rituximab was supplied in single-use vials.

Also known as: Rituxan, MabThera

Rituximab + methotrexate (Group A)

MethotrexateDRUG