Adults 18 to 65, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster VaccinePrimary· Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
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
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
39.1
Methotrexate (Group B)
42.3
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 VaccineSecondary· Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
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.
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
54.7
Methotrexate (Group B)
61.5
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 VaccineSecondary· Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccin
Serotype 1-146 (1)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
12.7
Methotrexate (Group B)
42.9
Serotype 3-146 (3)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
9.5
Methotrexate (Group B)
28.6
Serotype 4-146 (4)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
12.7
Methotrexate (Group B)
60.7
Serotype 6/26-146 (6B)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
38.1
Methotrexate (Group B)
60.7
Serotype 8-146 (8)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
33.3
Methotrexate (Group B)
57.1
Serotype 9-146 (9N)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
22.2
Methotrexate (Group B)
60.7
Serotype 12-146 (12F)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
11.1
Methotrexate (Group B)
50.0
Serotype 14-146 (14)
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
30.2
Methotrexate (Group B)
60.7
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 VaccineSecondary· Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccin
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
19.0
Methotrexate (Group B)
60.7
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 VaccineSecondary· Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of \> 1 μg/mL from pre-vaccin
1 serotype
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
57.1
Methotrexate (Group B)
82.1
2 serotypes
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
42.9
Methotrexate (Group B)
82.1
3 serotypes
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
38.1
Methotrexate (Group B)
78.6
4 serotypes
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
33.3
Methotrexate (Group B)
75.0
5 serotypes
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
23.8
Methotrexate (Group B)
67.9
Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster VaccineSecondary· Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B
Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. 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.
Pre-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
1.2
0.88 – 1.69
Methotrexate (Group B)
1.0
0.49 – 2.14
4 weeks post-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
4.0
2.72 – 5.74
Methotrexate (Group B)
5.2
2.25 – 12.00
Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide VaccineSecondary· Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B
Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.
Pre-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
0.8
0.64 – 1.06
Methotrexate (Group B)
1.0
0.68 – 1.47
4 weeks post-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
1.0
0.76 – 1.37
Methotrexate (Group B)
2.3
1.39 – 3.89
Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet HemocyaninSecondary· Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B
Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.
Pre-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
345.7
312.25 – 382.76
Methotrexate (Group B)
388.0
NA – NA
4 weeks post-vaccination
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
539.5
461.54 – 630.61
Methotrexate (Group B)
1585.5
1065.15 – 2360.17
Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group BSecondary· Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group B
Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
77.4
Methotrexate (Group B)
70.0
Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24Secondary· Week 24
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability I
ACR 20%
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
36.4
ACR 50%
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
21.2
ACR 70%
Group
Value
95% CI
Rituximab + Methotrexate (Group A)
4.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from Weeks 1-36 for Group A and Weeks 1-24 for Group B of the treatment period, Weeks 1-6 of the optional extension retreatment period, and Weeks 1-48 of the safety follow-up period (maximum of up to 90 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rituximab + Methotrexate (Group A) - Treatment Period
Serious: 3/68 (4%)
Deaths: —
Methotrexate (Group B) - Treatment Period
Serious: 2/32 (6%)
Deaths: —
Group A - Optional Extension Re-treatment Period
Serious: 2/52 (4%)
Deaths: —
Group B - Optional Extension Re-treatment Period
Serious: 2/26 (8%)
Deaths: —
Group A - Safety Follow-up Period
Serious: 3/68 (4%)
Deaths: —
Group B - Safety Follow-up Period
Serious: 1/32 (3%)
Deaths: —
Serious adverse events (11 terms)
Reaction
System
Rituximab + Methotrexate (…
Methotrexate (Group B) - T…
Group A - Optional Extensi…
Group B - Optional Extensi…
Group A - Safety Follow-up…
Group B - Safety Follow-up…
Coronary artery disease
Cardiac disorders
—
—
—
—
—
—
Chest pain
General disorders
—
—
—
—
—
—
Hip fracture
Infections and infestations
—
—
—
—
—
—
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Ovarian cyst
Reproductive system and breast disorders
—
—
—
—
—
—
Amaurosis fugax
Eye disorders
—
—
—
—
—
—
Pyelonephritis
Infections and infestations
—
—
—
—
—
—
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 10 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00282308.