Rheumatoid ArthritisPhase 2NCT00207714

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

A Phase 2 study testing Golimumab, MTX and Infliximab in people with Rheumatoid Arthritis, run by Centocor, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Golimumab, MTX and Infliximab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: No sites listed yet
Study dates: Nov 2003to Feb 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Who cannot join

Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose

About this study

Official title: A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Read the detailed description

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Conditions: Rheumatoid Arthritis
Being tested: Golimumab, MTX, Placebo, Infliximab
Keywords: Rheumatoid Arthritis, CNTO 148, Methotrexate, Joint pain, Arthritis
Medical subject headings: Arthritis, Rheumatoid, Arthralgia, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GolimumabDrug
Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
MTXDrug
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
PlaceboDrug
Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
InfliximabDrug
Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Study groups in NCT00207714
Study group	Role	What they receive
Golimumab (CNTO 148) with Methotrexate (MTX)	Experimental	Not described Receives: Drug: Golimumab; Drug: MTX
Infliximab with MTX	Experimental	Not described Receives: Drug: MTX; Drug: Infliximab
Placebo with MTX	Placebo comparator	Not described Receives: Drug: MTX; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Measured: Week 16

Secondary outcomes (1)

Summary of ACR-N, Index of Improvement at Week 16
The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Feb 2006

First posted21 Sep 2005 (estimated)
Study startNov 2003
Primary completionFeb 2005
Study completionFeb 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00207714
Sponsor's protocol ID: CR005263
Other IDs: C0524T02
Status last verified: Oct 2012
First submitted: 13 Sep 2005
Last updated: 18 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383.
PubMed 18383539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
ClinicalTrials.gov ID: NCT00207714
Acronym / sponsor ID: CR005263
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, CNTO 148, Methotrexate, Joint pain, Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Centocor, Inc.Industry (pharma, biotech, devices)
Collaborators: Centocor BV
Study start: Nov 2003
Primary completion: Feb 2005 (actual)
Study completion: Feb 2006 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Posted 7 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Golimumab (CNTO 148) with Methotrexate (MTX)	Experimental	Drug: Golimumab, Drug: MTX
Infliximab with MTX	Experimental	Drug: MTX, Drug: Infliximab
Placebo with MTX	Placebo comparator	Drug: MTX, Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Key exclusion criteria (2 listed)

Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GolimumabType=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.	Drug	Golimumab (CNTO 148) with Methotrexate (MTX)
MTXType=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous	Drug	Golimumab (CNTO 148) with Methotrexate (MTX), Infliximab with MTX, Placebo with MTX
PlaceboType=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous	Drug	Placebo with MTX
InfliximabType=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous	Drug	Infliximab with MTX

Primary outcome

Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16
Time frame: Week 16
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).

1 secondary outcome

Summary of ACR-N, Index of Improvement at Week 16
Time frame: Week 16

Results and safety

Results posted to the registry on 7 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I: Placebo Crossover to Infliximab	35	21
Group II: Golimumab 50 mg Every 4 Weeks	35	28
Group III: Golimumab 50 mg Every 2 or 4 Weeks	34	24
Group IV: Golibumab 100 mg Every 4 Weeks	34	26
Group V: Golimumab 100 mg Every 2 or 4 Weeks	34	29

Primary outcome: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16

Time frame: Week 16. Number. Unit: Participants

Measure	Group I: Placebo Crossover to Infliximab n = 35	Group II: Golimumab 50 mg Every 4 Weeks n = 35	Group III: Golimumab 50 mg Every 2 or 4 Weeks n = 34	Group IV: Golibumab 100 mg Every 4 Weeks n = 34	Group V: Golimumab 100 mg Every 2 or 4 Weeks n = 34	Combined: Groups II, III, IV & V n = 137
Value	13	21	17	19	27	84

Group I: Placebo Crossover to Infliximab vs Combined: Groups II, III, IV & V: p = 0.010, Cochran-Mantel-Haenszel
Group I: Placebo Crossover to Infliximab vs Group II: Golimumab 50 mg Every 4 Weeks: p = 0.056, Cochran-Mantel-Haenszel
Group I: Placebo Crossover to Infliximab vs Group III: Golimumab 50 mg Every 2 or 4 Weeks: p = 0.281, Cochran-Mantel-Haenszel

Population analysed: Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I: Placebo Crossover to Infliximab	2 of 34 (5.9%)	28 of 34 (82.4%)	Not reported
Group II: Golimumab 50 mg Every 4 Weeks	7 of 37 (18.9%)	34 of 37 (91.9%)	Not reported
Group III: Golimumab 50 mg Every 2 or 4 Weeks	5 of 32 (15.6%)	29 of 32 (90.6%)	Not reported
Group IV: Golibumab 100 mg Every 4 Weeks	5 of 33 (15.2%)	29 of 33 (87.9%)	Not reported
Group V: Golimumab 100 mg Every 2 or 4 Weeks	5 of 35 (14.3%)	33 of 35 (94.3%)	Not reported

Limitations and caveats (from the sponsor): The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 18383539Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383.

Related trials for Rheumatoid Arthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Centocor, Inc. Clinical Trial study director

Centocor, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Golimumab, MTX and Infliximab in people with Rheumatoid Arthritis, run by Centocor, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00207714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.