Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 86 sites in 6 countries.

Completed

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

Trial summary

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week. 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?: adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 420 participants
Where: 86 sitesin 6 countries
Study dates: Dec 2007to Apr 2009
Phase: Phase 3
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

Subject > 18 years of age
Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
Subject is judged to be in generally good health as determined by the principal investigator

Who cannot join

Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
Subject has a history of acute inflammatory joint disease of different origin other than RA
Subject has been treated with any investigational biologic agents
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Trial locations and contacts

86 sites in 6 countries.

Country

City, postcode or hospital

86 sites in 6 countries

United States48 sites

Study site
Ashville, North Carolina, 28801
Study site
Atlanta, Georgia, 30342
Study site
Aventura, Florida, 33180
Study site
Bend, Oregon, 97701
Study site
Bethlehem, Pennsylvania, 18015
Study site
Brighton, Michigan, 48116
Study site
Charleston, South Carolina, 29406
Study site
Charlotte, North Carolina, 28209
Study site
Chicago, Illinois, 60612
Study site
Covington, Louisiana, 70433
Study site
Dallas, Texas, 75235
Study site
Duncansville, Pennsylvania, 16635
Study site
Glendale, Wisconsin, 53217
Study site
Greenville, South Carolina, 29601
Study site
Hemet, California, 92543
Study site
Hickory, North Carolina, 28601
Study site
Houston, Texas, 77034
Study site
Houston, Texas, 77074
Study site
Huntsville, Alabama, 35801
Study site
Jackson, Tennessee, 38305
Study site
Lexington, Kentucky, 40515
Study site
Long Beach, California, 90806
Study site
Moline, Illinois, 61201
Study site
Monroe, North Carolina, 28112
Study site
Nashville, Tennessee, 37205
Study site
Ogden, Utah, 84405
Study site
Oklahoma City, Oklahoma, 73112
Study site
Olympia, Washington, 98502
Study site
Orange Park, Florida, 32073
Study site
Palm Harbor, Florida, 34684
Study site
Paradise Valley, Arizona, 85253
Study site
Passaic, New Jersey, 07055
Study site
Philadelphia, Pennsylvania, 19152
Study site
San Antonio, Texas, 78217
Study site
Santa Monica, California, 90404
Study site
Sarasota, Florida, 34239
Study site
Smithtown, New York, 11787
Study site
Springfield, Illinois, 62704
Study site
Tampa, Florida, 33614
Study site
The Bronx, New York, 10461
Study site
Torrance, California, 90505
Study site
Tuscaloosa, Alabama, 35406
Study site
Vero Beach, Florida, 32960
Study site
Victorville, California, 92395
Study site
West Hills, California, 91307
Study site
West Reading, Pennsylvania, 19611
Study site
Wheat Ridge, Colorado, 80033
Study site
Wichita, Kansas, 67203

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Canada18 sites

Study site
Burlington, Ontario, L7M 4Y1
Study site
Fredericton, New Brunswick, E3B 6H5
Study site
Hamilton, Ontario, L8N 1Y2
Study site
Hamilton, Ontario, L8N 2B6
Study site
Kitchener, Ontario, N2M 5N6
Study site
Lunenburg, Nova Scotia, B0J 2C0
Study site
Montreal, Quebec, H2L 1S6
Study site
Newmarket, Ontario, L3Y 3R7
Study site
Ottawa, Ontario, K1H 1A2
Study site
Québec, Quebec, G1V 3M7
Study site
Saint Catherines, Ontario, L2N 4H4
Study site
Saint-Eustache, Quebec, J7P 4J2
Study site
Sainte-Foy, Quebec, G1W 4R4
Study site
Sarnia, Ontario, N7T 5W6
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
Study site
Windsor, Ontario, N8X 5A6
Study site
Winnipeg, Manitoba, R3A 1M3
Study site
Winnipeg, Manitoba, R3N 0K6

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Germany8 sites

Study site
Bad Nauheim, D-61231
Study site
Berlin, D-14109
Study site
Buch, D-13125
Study site
Frankfurt, 60596
Study site
Freiburg im Breisgau, D-79106
Study site
München, 80639
Study site
Würzburg, D-97070
Study site
Zerbst, D-39261

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United Kingdom8 sites

Study site
Bath, Somerset, BA1 1RL
Study site
Cannock, Staffordshire, WS11 5XY
Study site
Huddersfield, York, HD3 3EA
Study site
Leeds, Yorkshire, LS7 4SA
Study site
Liverpool, Merseyside, L9 7AL
Study site
Metropolitan Borough of Wirral, Cheshire, CH49 5PE
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7 DN
Study site
Oxford, Oxfordshire, OX3 7LD

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Australia2 sites

Study site
Brisbane, Queensland, 4102
Study site
Cairns, Queensland, 4870

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Puerto Rico2 sites

Study site
Caguas, 00725
Study site
Ponce, 00716

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About this study

Official title: A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Read the detailed description

The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Conditions: Rheumatoid Arthritis
Being tested: adalimumab, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

adalimumabDrug
Also called ABT-D2E7, Humira
Pre-filled syringe. See arm for more detail
PlaceboDrug
Pre-filled syringe. See arm for more detail
adalimumabDrug
Also called ABT-D2E7, Humira
Pre-filled syringe. See arm for more detail

Study groups in NCT00647270
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo 12 weeks, 40mg adalimumab remaining 12 weeks Receives: Drug: Placebo
40 mg	Active comparator	40 mg every other week Receives: Drug: adalimumab
80 mg	Active comparator	80 mg monthly Receives: Drug: adalimumab

What is being measured

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

The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit
Measured: Week 12

Secondary outcomes (4)

Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Measured: Baseline and Week 12
Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Measured: Baseline and Week 12
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Measured: Baseline and Week 12
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Measured: Baseline and Week 12

Timeline

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

Dec 2007Apr 2009

First posted31 Mar 2008 (estimated)
Study startDec 2007
Primary completionApr 2009
Study completionApr 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00647270
Sponsor's protocol ID: M10-261
Status last verified: Apr 2011
First submitted: 27 Mar 2008
Last updated: 11 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PubMed 27338778

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?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
ClinicalTrials.gov ID: NCT00647270
Acronym / sponsor ID: M10-261
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 31 Mar 2008 (estimated)
Results: Posted 10 May 2010

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo 12 weeks, 40mg adalimumab remaining 12 weeks
40 mg	Active comparator	Drug: adalimumab40 mg every other week
80 mg	Active comparator	Drug: adalimumab80 mg monthly

Who may qualify

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

Key inclusion criteria (5 listed)

Subject > 18 years of age
Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
Subject is judged to be in generally good health as determined by the principal investigator

Key exclusion criteria (5 listed)

Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
Subject has a history of acute inflammatory joint disease of different origin other than RA
Subject has been treated with any investigational biologic agents
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

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
adalimumabAlso: ABT-D2E7, HumiraPre-filled syringe. See arm for more detail	Drug	40 mg
PlaceboPre-filled syringe. See arm for more detail	Drug	Placebo
adalimumabAlso: ABT-D2E7, HumiraPre-filled syringe. See arm for more detail	Drug	80 mg

Primary outcome

The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)
Time frame: Week 12
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit

4 secondary outcomes

Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
Time frame: Baseline and Week 12
Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: Baseline and Week 12
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
Time frame: Baseline and Week 12
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 10 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	56	48
Adalimumab 40 mg Eow	159	146
Adalimumab 80 mg Monthly	205	182

Primary outcome: The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)

Time frame: Week 12. Number. Unit: participants

Measure	Placebo n = 56	Adalimumab 40 mg Eow n = 159	Adalimumab 80 mg Monthly n = 205
Responders	19	80	97
Nonresponders	37	79	108

Placebo vs Adalimumab 80 mg Monthly: Mean Difference (Final Values): -3.0 (95% CI -13.3 to 7.4), p = 0.074, Chi-squared
Adalimumab 40 mg Eow vs Adalimumab 80 mg Monthly: p = 0.74, Chi-squared

Population analysed: Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Every Other Week (Eow)-Period 1	5 of 57 (8.8%)	13 of 57 (22.8%)	Not reported
Adalimumab 40 mg Eow -Period 1	8 of 164 (4.9%)	29 of 164 (17.7%)	Not reported
Adalimumab 80 mg Monthly-Period 1	4 of 211 (1.9%)	38 of 211 (18%)	Not reported
Placebo/Adalimumab 40 mg Eow-Period 2	1 of 49 (2%)	6 of 49 (12.2%)	Not reported
Adalimumab 40 mg Eow-Period 2	5 of 151 (3.3%)	14 of 151 (9.3%)	Not reported
Adalimumab 80 mg Monthly - Period 2	12 of 188 (6.4%)	11 of 188 (5.9%)	Not reported

Limitations and caveats (from the sponsor): Abbott identified Investigator non-compliance with the protocol requirements at one site and made the decision to exclude the data from this site from all efficacy analyses. Sample size was too small to demonstrate superiority and non-inferiority.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27338778Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

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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.

Laura Redden, MD study director

Abbott

86 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 86 sites in 6 countries.

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 5 inclusion and 5 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 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, Germany, United Kingdom, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 May 2010). 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?

The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow) (time frame: Week 12). 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 NCT00647270, 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 11 Apr 2011.