Rheumatoid ArthritisPhase 2986NCT01999192
Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis
A Phase 2 study testing Tregalizumab in people with Rheumatoid Arthritis, run by Biotest at 84 sites in 14 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone. The overall study duration is 24 weeks followed by a 24 week extension phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tregalizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 84 sitesin 14 countries
- Study dates
- Oct 2013to Jul 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject demonstrates active RA according to the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA with functional class I-III for ≥6 months.
- Subject receives oral or parenteral MTX treatment for ≥12 weeks (overall), with an unchanged mode of application and stable MTX dose of ≥15 mg per week (or ≥12.5 mg per week in case of MTX intolerance), but no more than the highest locally approved dose for RA, for ≥8 weeks prior to baseline. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. If applicable, the dose of folic acid must be unchanged for ≥8 weeks prior to baseline.
- Subject meets the following two criteria at both screening and baseline: - At least 6 swollen joints at 28-joint assessment. - At least 6 tender joints at 28-joint assessment.
- Subject has an erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) above the upper limit of normal (ULN) at screening. These tests may be repeated once during the screening period at the discretion of the investigator.
- Subject is ≥18 and ≤75 years of age.
- Subject has a body mass index ≥18 and ≤35 kg/m².
Show all 11Show fewer
- Subject receives treatment with corticosteroids ≤10 mg prednisone equivalent, stable for at least 4 weeks prior to baseline and during the study, if applicable.
- Subject receives treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable for at least 2 weeks prior to baseline and during the study, if applicable.
- Female subjects of childbearing potential: has both a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
- Subject is judged to be in good general health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (within 3 months before screening date is acceptable), and 12-lead electrocardiogram (ECG).
- Subject has a cluster of differentiation 4 (CD4) cell count of > 400/µl at screening.
Who cannot join
- Subject has previous exposure to any systemic biologic therapy (e.g., etanercept, adalimumab, rituximab, abatacept, tocilizumab), to Janus kinase (JAK) or spleen tyrosine kinase (SYK) inhibitors, or to Tregalizumab. Previous treatment with an anti-TNF agent is allowed only, if all of the following criteria apply: - treatment was stopped for reasons other than lack of efficacy or adverse events (AEs) - treatment was stopped at least 12 weeks or five half-lives of the compound prior to baseline (whichever is longer), and - the treatment period did not exceed 6 weeks.
- Subject received treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) apart from MTX in the 12 weeks prior to baseline, and for DMARD leflunomide in the 24 weeks prior to baseline (except where specific leflunomide wash-out procedures were completed, following applicable guidelines).
- Subject has been treated with intra-articular or parenteral administration of corticosteroids in the 4 weeks prior to baseline. Inhaled corticosteroids for stable medical conditions are allowed.
- Subject has undergone joint surgery in the 12 weeks prior to baseline (at joints to be assessed within the study) or has undergone major surgery (e.g., abdominal surgery) in the 8 weeks prior to baseline.
- Subject has a history of acute inflammatory joint disease of an origin other than RA or subject has any other rheumatic disease other than RA (e.g., mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus or any arthritis with onset prior to age 17 years). However, subjects may have secondary Sjögren's syndrome.
Trial locations and contacts
84 sites in 14 countries.
84 sites in 14 countries
Russia11 sites
Study Site 08
Kemerovo
Study Site 11
Kemerovo
Study Site 04
Kursk
Study Site 03
Moscow
Study Site 07
Moscow
Study Site 10
Moscow
Study Site 05
Omsk
Study Site 09
Saratov
Study Site 06
Smolensk
Study Site 01
Tomsk
Study Site 02
Yaroslavl
Poland10 sites
Study Site 08
Bialystok
Study Site 05
Bydgoszcz
Study Site 10
Elblag
Study Site 04
Gdynia
Study Site 02
Katowice
Study Site 03
Krakow
Study Site 06
Krakow
Study Site 09
Poznan
Study Site 01
Warsaw
Study Site 07
Warsaw
Czechia9 sites
Study Site 03
Bruntál
Study Site 05
Ostrava
Study Site 01
Prague
Study Site 04
Prague
Study Site 08
Prague
Study Site 09
Prague
Study Site 02
Uherské Hradiště
Study Site 07
Uherské Hradiště
Study Site 06
Zlín
Ukraine9 sites
Study Site 08
Donetsk
Study Site 01
Kharkiv
Study Site 02
Kharkiv
Study Site 03
Kyiv
Study Site 04
Kyiv
Study Site 05
Vinnytsia
Study Site 06
Vinnytsia
Study Site 07
Vinnytsia
Study Site 09
Zaporizhzhya
United States8 sites
Study Site 02
Clifton, New Jersey, 07012
Study Site 09
Houston, Texas, 77004
Study Site 05
Jackson, Tennessee, 38305
Study Site 10
Katy, Texas, 77450
Study Site 03
Lincoln, Nebraska, 68516
Study Site 04
North Charleston, South Carolina, 29406
Study Site 07
Paradise Valley, Arizona, 85253
Study Site 01
Springfield, Illinois, 62704
Bulgaria7 sites
Study Site 01
Plovdiv
Study Site 06
Plovdiv
Study Site 02
Sofia
Study Site 04
Sofia
Study Site 07
Sofia
Study Site 05
Stara Zagora
Study Site 03
Varna
Hungary6 sites
Study Site 03
Balatonfüred
Study Site 02
Budapest
Study Site 04
Budapest
Study Site 05
Budapest
Study Site 06
Gyula
Study Site 01
Veszprém
Germany5 sites
Study Site 03
Berlin
Study Site 04
Frankfurt
Study Site 06
München
Study Site 02
Ratingen
Study Site 01
Zerbst
Mexico5 sites
Study Site 02
Chihuahua City
Study Site 03
Distrito Federal
Study Site 06
León, Guanajuato
Study Site 05
Mexico City, Mexico City
Study Site 08
Mexico City, Mexico City
Slovakia5 sites
Study Site 03
Bratislava
Study Site 04
Kosice - Saca
Study Site 05
Lučenec
Study Site 02
Považská Bystrica
Study Site 01
Rimavská Sobota
Serbia4 sites
Study Site 01
Belgrade
Study Site 02
Belgrade
Study Site 04
Belgrade
Study Site 03
Niška Banja
About this study
Official title: A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.
The overall study duration is 24 weeks followed by a 24 week extension phase.
Read the detailed description
The planned clinical study 986 (TREAT 2b) is a 24-week study in patients with Active rheumatoid arthritis (RA) who have had an inadequate response to Methotrexate (MTX) alone. The main phase of this study is followed by a 24-week extension phase for subjects meeting the respective entry criteria. Patients will be randomized to one of three different Active treatment groups or Placebo. The primary efficacy variable is the proportion of subjects with an ACR20 response after 12 weeks of double blinded treatment with the study medication based on observed cases in the FAS.
At Week 12, all subjects who had a minimum improvement of at least 20% (from baseline) in their tender joint count (TJC) and swollen joint count (SJC) continued on the same treatment. Subjects who had not demonstrated an improvement of at least 20% of TJC and SJC were assessed as non-responders. Non-responders who received placebo were randomized to an active treatment dose in a blinded manner. Non-responders who received active treatment were rolled up to the next highest dose in a blinded manner, apart from those already on the highest dose. These subjects remained on the highest dose.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tregalizumab, Placebo
- Keywords
- inadequate response to MTX, Methotrexate, rheumatoid Arthritis, Phase 2b
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TregalizumabDrug
Also called BT061
humanized anti-CD4 mAb
PlaceboDrug
identical end formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 Tregalizumab | Experimental | 25mg Tregalizumab s.c. weekly Receives: Drug: Tregalizumab |
| Dose Level 2 Tregalizumab | Experimental | 100mg Tregalizumab s.c. weekly Receives: Drug: Tregalizumab |
| Dose Level 3 Tregalizumab | Experimental | 200mg Tregalizumab s.c. weekly Receives: Drug: Tregalizumab |
| Placebo | Placebo comparator | Placebo s.c. weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.
The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.
Measured: Week 12
Secondary outcomes (11)
Proportions of Subjects With an ACR 20 Response.
Measured: Week 24
Proportions of Subjects With an ACR 50 & 70 Response.
Measured: Week 12 & Week 24
Proportions of Subjects With an Disease Activity Score DAS28 <2.6
Measured: Week 12 & Week 24
Proportions of Subjects With Low Disease Activity DAS28 ≤3.2
Measured: Week 12 & Week 24
ACR Score
Measured: up to 48 weeks
Simple Disease Activity Index [SDAI] ≤11
Measured: week 12 & 24
Clinical Disease Activity Index [CDAI] ≤10
Measured: week 12 & 24
DAS28
Measured: up to 48 weeks
EULAR Response
Measured: up to 48 weeks
ACR Score Individual Components
Measured: up to 48 weeks
DAS28 Score Individual Components
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Lack of efficacy
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Ronald van Vollenhoven, Prof. MD, Principal investigator, Karolinska Universitetssjukhuset, Solna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999192
- Sponsor's protocol ID
- 986_TREAT 2b
- Other IDs
- 2013-000114-38, BT986
- Acronym
- 986
- Status last verified
- Jul 2017
- First submitted
- 17 Nov 2013
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van Vollenhoven RF, Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Racewicz A, Zipp D, Rharbaoui F, Wolter R, Knierim L, Schmeidl R, Zhou X, Aigner S, Dalken B, Wartenberg-Demand A; TREAT2b study team. Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial. Ann Rheum Dis. 2018 Apr;77(4):495-499. doi: 10.1136/annrheumdis-2017-212478. Epub 2018 Jan 17.
PubMed 29343509
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)
- ClinicalTrials.gov ID
- NCT01999192
- Acronym / sponsor ID
- 986 / 986_TREAT 2b
- Conditions
- Rheumatoid Arthritis
- Keywords
- inadequate response to MTX, Methotrexate, rheumatoid Arthritis, Phase 2b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 321 participants (actual)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.
The overall study duration is 24 weeks followed by a 24 week extension phase.
Detailed description
The planned clinical study 986 (TREAT 2b) is a 24-week study in patients with Active rheumatoid arthritis (RA) who have had an inadequate response to Methotrexate (MTX) alone. The main phase of this study is followed by a 24-week extension phase for subjects meeting the respective entry criteria. Patients will be randomized to one of three different Active treatment groups or Placebo. The primary efficacy variable is the proportion of subjects with an ACR20 response after 12 weeks of double blinded treatment with the study medication based on observed cases in the FAS.
At Week 12, all subjects who had a minimum improvement of at least 20% (from baseline) in their tender joint count (TJC) and swollen joint count (SJC) continued on the same treatment. Subjects who had not demonstrated an improvement of at least 20% of TJC and SJC were assessed as non-responders. Non-responders who received placebo were randomized to an active treatment dose in a blinded manner. Non-responders who received active treatment were rolled up to the next highest dose in a blinded manner, apart from those already on the highest dose. These subjects remained on the highest dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 Tregalizumab | Experimental | Drug: Tregalizumab25mg Tregalizumab s.c. weekly |
| Dose Level 2 Tregalizumab | Experimental | Drug: Tregalizumab100mg Tregalizumab s.c. weekly |
| Dose Level 3 Tregalizumab | Experimental | Drug: Tregalizumab200mg Tregalizumab s.c. weekly |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo s.c. weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject demonstrates active RA according to the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA with functional class I-III for ≥6 months.
- Subject receives oral or parenteral MTX treatment for ≥12 weeks (overall), with an unchanged mode of application and stable MTX dose of ≥15 mg per week (or ≥12.5 mg per week in case of MTX intolerance), but no more than the highest locally approved dose for RA, for ≥8 weeks prior to baseline. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. If applicable, the dose of folic acid must be unchanged for ≥8 weeks prior to baseline.
- Subject meets the following two criteria at both screening and baseline: - At least 6 swollen joints at 28-joint assessment. - At least 6 tender joints at 28-joint assessment.
- Subject has an erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) above the upper limit of normal (ULN) at screening. These tests may be repeated once during the screening period at the discretion of the investigator.
- Subject is ≥18 and ≤75 years of age.
Key exclusion criteria (5 listed)
- Subject has previous exposure to any systemic biologic therapy (e.g., etanercept, adalimumab, rituximab, abatacept, tocilizumab), to Janus kinase (JAK) or spleen tyrosine kinase (SYK) inhibitors, or to Tregalizumab. Previous treatment with an anti-TNF agent is allowed only, if all of the following criteria apply: - treatment was stopped for reasons other than lack of efficacy or adverse events (AEs) - treatment was stopped at least 12 weeks or five half-lives of the compound prior to baseline (whichever is longer), and - the treatment period did not exceed 6 weeks.
- Subject received treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) apart from MTX in the 12 weeks prior to baseline, and for DMARD leflunomide in the 24 weeks prior to baseline (except where specific leflunomide wash-out procedures were completed, following applicable guidelines).
- Subject has been treated with intra-articular or parenteral administration of corticosteroids in the 4 weeks prior to baseline. Inhaled corticosteroids for stable medical conditions are allowed.
- Subject has undergone joint surgery in the 12 weeks prior to baseline (at joints to be assessed within the study) or has undergone major surgery (e.g., abdominal surgery) in the 8 weeks prior to baseline.
- Subject has a history of acute inflammatory joint disease of an origin other than RA or subject has any other rheumatic disease other than RA (e.g., mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus or any arthritis with onset prior to age 17 years). However, subjects may have secondary Sjögren's syndrome.
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 |
|---|---|---|
| TregalizumabAlso: BT061humanized anti-CD4 mAb | Drug | Dose Level 1 Tregalizumab, Dose Level 2 Tregalizumab, Dose Level 3 Tregalizumab |
| Placeboidentical end formulation buffer | Drug | Placebo |
Primary outcome
The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
Time frame: Week 12
The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication. The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.
11 secondary outcomes
Proportions of Subjects With an ACR 20 Response.
Time frame: Week 24
Proportions of Subjects With an ACR 50 & 70 Response.
Time frame: Week 12 & Week 24
Proportions of Subjects With an Disease Activity Score DAS28 <2.6
Time frame: Week 12 & Week 24
Proportions of Subjects With Low Disease Activity DAS28 ≤3.2
Time frame: Week 12 & Week 24
ACR Score
Time frame: up to 48 weeks
Simple Disease Activity Index [SDAI] ≤11
Time frame: week 12 & 24
Clinical Disease Activity Index [CDAI] ≤10
Time frame: week 12 & 24
DAS28
Time frame: up to 48 weeks
EULAR Response
Time frame: up to 48 weeks
ACR Score Individual Components
Time frame: up to 48 weeks
DAS28 Score Individual Components
Time frame: up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29343509van Vollenhoven RF, Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Racewicz A, Zipp D, Rharbaoui F, Wolter R, Knierim L, Schmeidl R, Zhou X, Aigner S, Dalken B, Wartenberg-Demand A; TREAT2b study team. Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial. Ann Rheum Dis. 2018 Apr;77(4):495-499. doi: 10.1136/annrheumdis-2017-212478. Epub 2018 Jan 17.
- Individual participant dataSharing planned: No
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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.
Ronald van Vollenhoven, Prof. MD principal investigator
Karolinska Universitetssjukhuset, Solna
84 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tregalizumab in people with Rheumatoid Arthritis, run by Biotest at 84 sites in 14 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 11 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: stopped early, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in Russia, Poland, Czechia, Ukraine, United States and 9 more countries. 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 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 24 Aug 2017). 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 Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX (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 NCT01999192, 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 24 Aug 2017.